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Tretinoin Capsules Prescribing Information

Drug Detail:Tretinoin (systemic) (monograph) (Vesanoid)

Drug Class:

Contents
Uses Warnings Before Taking Dosage Side effects Interactions FAQ

Rx only

WARNINGS

1. Experienced Physician and Institution
Patients with acute promyelocytic leukemia (APL) are at high risk in general and can have severe adverse reactions to tretinoin. Tretinoin should therefore be administered only to patients with APL under the strict supervision of a physician who is experienced in the management of patients with acute leukemia and in a facility with laboratory and supportive services sufficient to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity, including respiratory compromise. Use of tretinoin requires that the physician concludes that the possible benefit to the patient outweighs the following known adverse effects of the therapy.

2. Retinoic Acid-APL Syndrome
About 25% of patients with APL treated with tretinoin have experienced a syndrome called the retinoic acid-APL (RA-APL) syndrome characterized by fever, dyspnea, acute respiratory distress, weight gain, radiographic pulmonary infiltrates, pleural and pericardial effusions, edema, and hepatic, renal, and multi-organ failure. This syndrome has occasionally been accompanied by impaired myocardial contractility and episodic hypotension. It has been observed with or without concomitant leukocytosis. Endotracheal intubation and mechanical ventilation have been required in some cases due to progressive hypoxemia, and several patients have expired with multi-organ failure. The syndrome generally occurs during the first month of treatment, with some cases reported following the first dose of tretinoin.

The management of the syndrome has not been defined rigorously, but high-dose steroids given at the first suspicion of the RA-APL syndrome appear to reduce morbidity and mortality. At the first signs suggestive of the syndrome (unexplained fever, dyspnea and/or weight gain, abnormal chest auscultatory findings or radiographic abnormalities), high-dose steroids (dexamethasone 10 mg intravenously administered every 12 hours for 3 days or until the resolution of symptoms) should be immediately initiated, irrespective of the leukocyte count. The majority of patients do not require termination of tretinoin therapy during treatment of the RA-APL syndrome. However, in cases of moderate and severe RA-APL syndrome, temporary interruption of tretinoin therapy should be considered. [ 1]

3. Leukocytosis at Presentation and Rapidly Evolving Leukocytosis During Tretinoin Treatment
During tretinoin treatment about 40% of patients will develop rapidly evolving leukocytosis. Patients who present with high WBC at diagnosis (>5x10 9/L) have an increased risk of a further rapid increase in WBC counts. Rapidly evolving leukocytosis is associated with a higher risk of life-threatening complications.

If signs and symptoms of the RA-APL syndrome are present together with leukocytosis, treatment with high-dose steroids should be initiated immediately. Some investigators routinely add chemotherapy to tretinoin treatment in the case of patients presenting with a WBC count of >5x10 9/L or in the case of a rapid increase in WBC count for patients leukopenic at start of treatment, and have reported a lower incidence of the RA-APL syndrome. Consideration could be given to adding full-dose chemotherapy (including an anthracycline if not contraindicated) to the tretinoin therapy on day 1 or 2 for patients presenting with a WBC count of >5x10 9/L, or immediately, for patients presenting with a WBC count of <5x10 9/L, if the WBC count reaches ≥6x10 9/L by day 5, or ≥10x10 9/L by day 10, or ≥15x10 9/L by day 28.

4. Teratogenic Effects. Pregnancy Category D–see WARNINGS
There is a high risk that a severely deformed infant will result if tretinoin is administered during pregnancy. If, nonetheless, it is determined that tretinoin represents the best available treatment for a pregnant woman or a woman of childbearing potential, it must be assured that the patient has received full information and warnings of the risk to the fetus if she were to be pregnant and of the risk of possible contraception failure and has been instructed in the need to use two reliable forms of contraception simultaneously during therapy and for 1 month following discontinuation of therapy, and has acknowledged her understanding of the need for using dual contraception, unless abstinence is the chosen method.

Within 1 week prior to the institution of tretinoin therapy, the patient should have blood or urine collected for a serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL. When possible, tretinoin therapy should be delayed until a negative result from this test is obtained. When a delay is not possible, the patient should be placed on two reliable forms of contraception. Pregnancy testing and contraception counseling should be repeated monthly throughout the period of tretinoin treatment.

Tretinoin Capsules - Clinical Pharmacology

Pharmacokinetics

Tretinoin activity is primarily due to the parent drug. In human pharmacokinetics studies, orally administered drug was well absorbed into the systemic circulation, with approximately two-thirds of the administered radiolabel recovered in the urine. The terminal elimination half-life of tretinoin following initial dosing is 0.5 to 2 hours in patients with APL. There is evidence that tretinoin induces its own metabolism. Plasma tretinoin concentrations decrease on average to one-third of their day 1 values during 1 week of continuous therapy. Mean ± SD peak tretinoin concentrations decreased from 394 ± 89 to 138 ± 139 ng/mL, while area under the curve (AUC) values decreased from 537 ± 191 ng·h/mL to 249 ± 185 ng·h/mL during 45 mg/m 2 daily dosing in 7 APL patients. Increasing the dose to “correct” for this change has not increased response.

Distribution

The apparent volume of distribution of tretinoin has not been determined. Tretinoin is greater than 95% bound in plasma, predominately to albumin. Plasma protein binding remains constant over the concentration range of 10 to 500 ng/mL.

Metabolism

Tretinoin metabolites have been identified in plasma and urine. Cytochrome P450 enzymes have been implicated in the oxidative metabolism of tretinoin. Metabolites include 13- cis retinoic acid, 4-oxo trans retinoic acid, 4-oxo cis retinoic acid, and 4-oxo trans retinoic acid glucuronide. In APL patients, daily administration of a 45 mg/m 2 dose of tretinoin resulted in an approximately tenfold increase in the urinary excretion of 4-oxo trans retinoic acid glucuronide after 2 to 6 weeks of continuous dosing, when compared to baseline values.

Excretion

Studies with radiolabeled drug have demonstrated that after the oral administration of 2.75 and 50 mg doses of tretinoin, greater than 90% of the radioactivity was recovered in the urine and feces. Based upon data from 3 subjects, approximately 63% of radioactivity was recovered in the urine within 72 hours and 31% appeared in the feces within 6 days.

Special Populations

The pharmacokinetics of tretinoin have not been separately evaluated in women, in members of different ethnic groups, or in individuals with renal or hepatic insufficiency.

Drug-Drug Interactions

In 13 patients who had received daily doses of tretinoin for 4 consecutive weeks, administration of ketoconazole (400 to 1200 mg oral dose) 1 hour prior to the administration of the tretinoin dose on day 29 led to a 72% increase (218 ± 224 vs 375 ± 285 ng·h/mL) in tretinoin mean plasma AUC. The precise cytochrome P450 enzymes involved in these interactions have not been specified; CYP 3A4, 2C8 and 2E have been implicated in various preliminary reports.

Clinical Studies

Tretinoin has been investigated in 114 previously treated APL patients and in 67 previously untreated (“de novo”) patients in one open-label, uncontrolled single investigator clinical study (Memorial Sloan-Kettering Cancer Center [MSKCC]) and in two cohorts of compassionate cases treated by multiple investigators under the auspices of the National Cancer Institute (NCI). All patients received 45 mg/m 2/day as a divided oral dose for up to 90 days or 30 days beyond the day that CR was reached. Results are shown in the following table:

MSKCCNCI Cohort 1NCI Cohort 2
Relapsed
N=20		De Novo
n=15		Relapsed*
n=48		De Novo
n=14		Relapsed
n=46		De Novo†
n=38

Complete Remission

16 (80%)

11 (73%)

24 (50%)

5 (36%)

24 (52%)

26 (68%)

Median Survival (Mo)

10.8

NR

5.8

0.5

8.8

NR

Median Follow-up (Mo)

9.9

42.9

5.6

1.2

8.0

13.1

RA-APL Syndrome

4 (20%)

5 (33%)

10 (21%)

6 (43%)

NA

NA

NR = Not Reached
NA = Not Available
* Including 9 chemorefractory patients
† Including 8 patients who received chemotherapy but failed to enter remission


The median time to CR was between 40 and 50 days (range: 2 to 120 days). Most patients in these studies received cytotoxic chemotherapy during the remission phase. These results compare to the 30% to 50% CR rate and ≤6 month median survival reported for cytotoxic chemotherapy of APL in the treatment of relapse.

Ten of 15 pediatric cases achieved CR (8 of 10 males and 2 of 5 females). There were insufficient patients of black, Hispanic or Asian derivation to estimate relative response rates in these groups, but responses were seen in each category.

Responses were seen in 3 of 4 patients for whom cytogenetic analysis failed to detect the t(15;17) translocation typically seen in APL. The t(15;17) translocation results in the PML/RARα gene, which appears necessary for this disease. Molecular genetic studies were not conducted in these cases, but it is likely they represent cases with a masked translocation giving rise to PML/RARα. Responses to tretinoin have not been observed in cases in which PML/RARα fusion has been shown to be absent.

Warnings

Pregnancy Category D – See Boxed WARNINGS

Tretinoin has teratogenic and embryotoxic effects in mice, rats, hamsters, rabbits and pigtail monkeys, and may be expected to cause fetal harm when administered to a pregnant woman. Tretinoin causes fetal resorptions and a decrease in live fetuses in all animals studied. Gross external, soft tissue and skeletal alterations occurred at doses higher than 0.7 mg/kg/day in mice, 2 mg/kg/day in rats, 7 mg/kg/day in hamsters, and at a dose of 10 mg/kg/day, the only dose tested, in pigtail monkeys (about 1/20, 1/4, and 1/2 and 4 times the human dose, respectively, on a mg/m 2 basis).

There are no adequate and well-controlled studies in pregnant women. Although experience with humans administered tretinoin is extremely limited, increased spontaneous abortions and major human fetal abnormalities related to the use of other retinoids have been documented in humans. Reported defects include abnormalities of the CNS, musculoskeletal system, external ear, eye, thymus and great vessels; and facial dysmorphia, cleft palate, and parathyroid hormone deficiency. Some of these abnormalities were fatal. Cases of IQ scores less than 85, with or without obvious CNS abnormalities, have also been reported. All fetuses exposed during pregnancy can be affected and at the present time there is no antepartum means of determining which fetuses are and are not affected.

Effective contraception must be used by all females during tretinoin therapy and for 1 month following discontinuation of therapy. Contraception must be used even when there is a history of infertility or menopause, unless a hysterectomy has been performed. Whenever contraception is required, it is recommended that two reliable forms of contraception be used simultaneously, unless abstinence is the chosen method. If pregnancy does occur during treatment, the physician and patient should discuss the desirability of continuing or terminating the pregnancy.

Patients Without the t(15;17) Translocation

Initiation of therapy with tretinoin may be based on the morphological diagnosis of acute promyelocytic leukemia. Confirmation of the diagnosis of APL should be sought by detection of the t(15;17) genetic marker by cytogenetic studies. If these are negative, PML/RARα fusion should be sought using molecular diagnostic techniques. The response rate of other AML subtypes to tretinoin has not been demonstrated; therefore, patients who lack the genetic marker should be considered for alternative treatment.

Retinoic Acid-APL (RA-APL) Syndrome

In up to 25% of patients with APL treated with tretinoin, a syndrome occurs which can be fatal (see boxed WARNINGS and ADVERSE REACTIONS).

Leukocytosis at Presentation and Rapidly Evolving Leukocytosis During Tretinoin Treatment

See boxed WARNINGS.

Pseudotumor Cerebri

Retinoids, including tretinoin, have been associated with pseudotumor cerebri (benign intracranial hypertension), especially in pediatric patients. The concomitant use of other agents known to cause pseudotumor cerebri/intracranial hypertension, such as tetracyclines, might increase the risk of this condition (see PRECAUTIONS: Drug Interactions). [ 2] Early signs and symptoms of pseudotumor cerebri include papilledema, headache, nausea and vomiting, and visual disturbances. Patients with these symptoms should be evaluated for pseudotumor cerebri, and, if present, appropriate care should be instituted in concert with neurological assessment.

Lipids

Up to 60% of patients experienced hypercholesterolemia and/or hypertriglyceridemia, which were reversible upon completion of treatment. The clinical consequences of temporary elevation of triglycerides and cholesterol are unknown, but venous thrombosis and myocardial infarction have been reported in patients who ordinarily are at low risk for such complications.

Elevated Liver Function Test Results

Elevated liver function test results occur in 50% to 60% of patients during treatment. Liver function test results should be carefully monitored during treatment and consideration be given to a temporary withdrawal of tretinoin if test results reach >5 times the upper limit of normal values. However, the majority of these abnormalities resolve without interruption of tretinoin or after completion of treatment.

Precautions

Drug Interactions

Limited clinical data on potential drug interactions are available.

Drugs Metabolized By the Hepatic P450 System

As tretinoin is metabolized by the hepatic P450 system, there is a potential for alteration of pharmacokinetics parameters in patients administered concomitant medications that are also inducers or inhibitors of this system. Medications that generally induce hepatic P450 enzymes include rifampicin, glucocorticoids, phenobarbital and pentobarbital. Medications that generally inhibit hepatic P450 enzymes include ketoconazole, cimetidine, erythromycin, verapamil, diltiazem and cyclosporine. To date there are no data to suggest that co-use with these medications increases or decreases either efficacy or toxicity of tretinoin.

Agents Known to Cause Pseudotumor Cerebri/Intracranial Hypertension (Such as Tetracyclines)

Tretinoin may cause pseudotumor cerebri/intracranial hypertension. Concomitant administration of tretinoin and agents known to cause pseudotumor cerebri/intracranial hypertension as well might increase the risk of this condition (see WARNINGS).

Vitamin A

As with other retinoids, tretinoin must not be administered in combination with vitamin A because symptoms of hypervitaminosis A could be aggravated.

Anti-fibrinolytic Agents (Such as Tranexamic Acid, Aminocaproic Acid, or Aprotinin)

Cases of fatal thrombotic complications have been reported rarely in patients concomitantly treated with tretinoin and anti-fibrinolytic agents. Therefore, caution should be exercised when administering tretinoin concomitantly with these agents (see PRECAUTIONS: General).

Effect of Food

No data on the effect of food on the absorption of tretinoin are available. The absorption of retinoids as a class has been shown to be enhanced when taken together with food.

Adverse Reactions/Side Effects

Virtually all patients experience some drug-related toxicity, especially headache, fever, weakness, and fatigue. These adverse effects are seldom permanent or irreversible nor do they usually require interruption of therapy. Some of the adverse events are common in patients with APL, including hemorrhage, infections, gastrointestinal hemorrhage, disseminated intravascular coagulation, pneumonia, septicemia, and cerebral hemorrhage. The following describes the adverse events, regardless of drug relationship, that were observed in patients treated with tretinoin.

Typical Retinoid Toxicity

The most frequently reported adverse events were similar to those described in patients taking high doses of vitamin A and included headache (86%), fever (83%), skin/mucous membrane dryness (77%), bone pain (77%), nausea/vomiting (57%), rash (54%), mucositis (26%), pruritus (20%), increased sweating (20%), visual disturbances (17%), ocular disorders (17%), alopecia (14%), skin changes (14%), changed visual acuity (6%), bone inflammation (3%), visual field defects (3%).

RA-APL Syndrome

APL patients treated with tretinoin have experienced a potentially fatal syndrome characterized by fever, dyspnea, acute respiratory distress, weight gain, radiographic pulmonary infiltrates, pleural and pericardial effusions, edema, and hepatic, renal, and multi-organ failure. This syndrome has occasionally been accompanied by impaired myocardial contractility and episodic hypotension and has been observed with or without concomitant leukocytosis. Some patients have expired due to progressive hypoxemia and multi-organ failure. The syndrome generally occurs during the first month of treatment, with some cases reported following the first dose of tretinoin. The management of the syndrome has not been defined rigorously, but high-dose steroids given at the first signs of the syndrome appear to reduce morbidity and mortality. Treatment with dexamethasone, 10 mg intravenously administered every 12 hours for 3 days or until resolution of symptoms, should be initiated without delay at the first suspicion of symptoms (one or more of the following: fever, dyspnea, weight gain, abnormal chest auscultatory findings or radiographic abnormalities). Sixty percent or more of patients treated with tretinoin may require high-dose steroids because of these symptoms. The majority of patients do not require termination of tretinoin therapy during treatment of the syndrome.

Body as a Whole

General disorders related to tretinoin administration and/or associated with APL included malaise (66%), shivering (63%), hemorrhage (60%), infections (58%), peripheral edema (52%), pain (37%), chest discomfort (32%), edema (29%), disseminated intravascular coagulation (26%), weight increase (23%), injection site reactions (17%), anorexia (17%), weight decrease (17%), myalgia (14%), flank pain (9%), cellulitis (8%), face edema (6%), fluid imbalance (6%), pallor (6%), lymph disorders (6%), acidosis (3%), hypothermia (3%), ascites (3%).

Respiratory System Disorders

Respiratory system disorders were commonly reported in APL patients administered tretinoin. The majority of these events are symptoms of the RA-APL syndrome (see boxed WARNINGS). Respiratory system adverse events included upper respiratory tract disorders (63%), dyspnea (60%), respiratory insufficiency (26%), pleural effusion (20%), pneumonia (14%), rales (14%), expiratory wheezing (14%), lower respiratory tract disorders (9%), pulmonary infiltration (6%), bronchial asthma (3%), pulmonary edema (3%), larynx edema (3%), unspecified pulmonary disease (3%).

Ear Disorders

Ear disorders were consistently reported, with earache or feeling of fullness in the ears reported by 23% of the patients. Hearing loss and other unspecified auricular disorders were observed in 6% of patients, with infrequent (<1%) reports of irreversible hearing loss.

Gastrointestinal Disorders

GI disorders included GI hemorrhage (34%), abdominal pain (31%), other gastrointestinal disorders (26%), diarrhea (23%), constipation (17%), dyspepsia (14%), abdominal distention (11%), hepatosplenomegaly (9%), hepatitis (3%), ulcer (3%), unspecified liver disorder (3%).

Cardiovascular and Heart Rate and Rhythm Disorders

Arrhythmias (23%), flushing (23%), hypotension (14%), hypertension (11%), phlebitis (11%), cardiac failure (6%) and for 3% of patients: cardiac arrest, myocardial infarction, enlarged heart, heart murmur, ischemia, stroke, myocarditis, pericarditis, pulmonary hypertension, secondary cardiomyopathy.

Central and Peripheral Nervous System Disorders and Psychiatric

Dizziness (20%), paresthesias (17%), anxiety (17%), insomnia (14%), depression (14%), confusion (11%), cerebral hemorrhage (9%), intracranial hypertension (9%), agitation (9%), hallucination (6%) and for 3% of patients: abnormal gait, agnosia, aphasia, asterixis, cerebellar edema, cerebellar disorders, convulsions, coma, CNS depression, dysarthria, encephalopathy, facial paralysis, hemiplegia, hyporeflexia, hypotaxia, no light reflex, neurologic reaction, spinal cord disorder, tremor, leg weakness, unconsciousness, dementia, forgetfulness, somnolence, slow speech.

Urinary System Disorders

Renal insufficiency (11%), dysuria (9%), acute renal failure (3%), micturition frequency (3%), renal tubular necrosis (3%), enlarged prostate (3%).

Miscellaneous Adverse Events

Isolated cases of erythema nodosum, basophilia and hyperhistaminemia, Sweet’s syndrome, organomegaly, hypercalcemia, pancreatitis and myositis have been reported.

Additional Adverse Reactions Reported With Tretinoin

Cardiovascular

Cases of thrombosis (both venous and arterial) involving various sites (eg, cerebrovascular accident, myocardial infarction, renal infarct) have been reported rarely (see PRECAUTIONS: General).

Hematologic

Rare cases of thrombocytosis have been reported. [ 6]

Skin

Genital ulceration [ 7]

Miscellaneous Adverse Events

Rare cases of vasculitis, predominantly involving the skin, have been reported. [ 8]

To report SUSPECTED ADVERSE REACTIONS contact AvKARE at 1-855-361-3993; email drugsafety@[email protected]; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

ANNOTATIONS

1. Tallman MS, et al. Clinical description of 44 patients with acute promyelocytic leukemia who developed retinoic acid syndrome. Blood. 2000; 95(1): 90-95.

2. Longauer M. Drug Safety Report No. 1007960: Concomitant use of tetracyclines. March 27, 2002.

3. Longauer M. Drug Safety Report No. 1008342: Thromboses involving any sites. March 27, 2002.

4. Longauer M. Issue Work-Up: Safety of concomitant administration of Tretinoin and anti-fibrinolytic agents. May 4, 2001.

5. Longauer M. Drug Safety Report No. 1007959: Interaction with low-dose progestogens (“minipill”). March 27, 2002.

6. Longauer M. Issue Work-Up: Thrombocytosis. December 18, 2000.

7. Longauer M. Safety Evaluation Update: Genital Ulcerations. Provided in Periodic Safety Update Report on Tretinoin Oral Period: April 1, 1998-March 31, 1991 (Research Report No. B-170’967, May 31, 1999).

8. Longauer M. Issue Work-Up: Vasculitis. September 26, 2000.

Manufactured for:

AvKARE
Pulaski, TN 38478
www.avkare.com

Mfg. Rev. 02/16
AV 02/22 (P)

INFORMATION FOR THE PATIENT

WARNING TO FEMALE PATIENTS

YOU MUST NOT BECOME PREGNANT DURING TRETINOIN TREATMENT. There is an extremely high risk that a deformed baby will result if you become pregnant while taking tretinoin , in any amount, for even short periods of time. Potentially any exposed fetuses can be affected. There is also an increased risk of miscarriage. Premature births may also occur.

Effective contraception (birth control) should be discussed with your doctor. Two forms of reliable contraception must be used during therapy, and must be continued for one month after tretinoin treatment has stopped. If directed by your doctor, two forms of reliable contraception must also be used simultaneously for at least one month before beginning therapy. It is recommended that you either abstain from sexual intercourse or use two reliable kinds of birth control at the same time. Birth control must be used even if you think you cannot become pregnant, unless you have had a hysterectomy.

If you are pregnant or become pregnant while on tretinoin therapy or during the month after treatment has stopped, immediately contact your doctor to discuss the desirability of continuing the pregnancy.

YOU MUST NOT TAKE TRETINOIN IF YOU ARE A NURSING MOTHER.

Tretinoin should not be taken by nursing mothers since it is not known whether it is excreted in human milk. Since many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from tretinoin, mothers should discontinue nursing prior to taking this drug.

General guidelines for taking your medication...

  • Call your doctor if you have any questions or experience any severe or troubling symptoms.
  • Tretinoin does not need to be refrigerated. However, do not expose the capsules to sunlight or excessive heat.
  • Be sure to take your medication as prescribed by your doctor. Read the prescription label on the package carefully. If there is anything you don’t understand, ask your doctor or pharmacist to explain it to you.
  • Keep tretinoin and all medications out of the reach of children.

Store at 20° to 25°C (68° to 77°F) [see USP controlled room temperature].

Protect from light.

Manufactured for:
AvKARE
Pulaski, TN 38478
www.avkare.com

Mfg. Rev. 02/16
AV 02/22 (P)

TRETINOIN
tretinoin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42291-870(NDC:68462-792)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R) TRETINOIN10 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
SOYBEAN OIL (UNII: 241ATL177A)
YELLOW WAX (UNII: 2ZA36H0S2V)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
AMMONIA (UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
OLEIC ACID (UNII: 2UMI9U37CP)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
TOCOPHEROL (UNII: R0ZB2556P8)
SUNFLOWER OIL (UNII: 3W1JG795YI)
Product Characteristics
Colorpink (Opaque Cap) Scoreno score
ShapeCAPSULESize10mm
FlavorImprint CodeT;10
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42291-870-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/23/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20827902/23/2022
Labeler - AvKARE (796560394)

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