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Serving leading biopharmaceutical companies globally:

Cerilliant
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Federal Trade Commission
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Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076498

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NDA 076498 describes TRETINOIN, which is a drug marketed by Anchen Pharms, Barr Labs Inc, Glenmark Pharms Ltd, Allergan Sales Llc, Perrigo Pharma Intl, Zo Skin Health, Mylan Pharms Inc, Teva Pharms, and Wockhardt, and is included in sixteen NDAs. It is available from seventeen suppliers. Additional details are available on the TRETINOIN profile page.

The generic ingredient in TRETINOIN is tretinoin. There are twenty-four drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the tretinoin profile page.
Summary for 076498
Tradename:TRETINOIN
Applicant:Zo Skin Health
Ingredient:tretinoin
Patents:0
Therapeutic Class:Antineoplastics
Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076498
Ingredient-typeRetinoids
Medical Subject Heading (MeSH) Categories for 076498
Suppliers and Packaging for NDA: 076498
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRETINOIN tretinoin CREAM;TOPICAL 076498 ANDA ZO Skin Health, Inc. 42851-011 42851-011-40 1 TUBE in 1 CARTON (42851-011-40) > 40 g in 1 TUBE
TRETINOIN tretinoin CREAM;TOPICAL 076498 ANDA ZO Skin Health, Inc. 42851-011 42851-011-20 1 TUBE in 1 CARTON (42851-011-20) > 20 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.05%
Approval Date:Sep 15, 2005TE:AB2RLD:No

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McKesson
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