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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075264

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NDA 075264 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 eighteen 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-seven suppliers are listed for this compound. Additional details are available on the tretinoin profile page.

Summary for 075264

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antineoplastics
Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075264

Ingredient-typeRetinoids

Medical Subject Heading (MeSH) Categories for 075264

Suppliers and Packaging for NDA: 075264

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRETINOIN tretinoin CREAM;TOPICAL 075264 ANDA Paddock Laboratories, LLC 0574-2225 0574-2225-20 1 TUBE in 1 CARTON (0574-2225-20) > 20 g in 1 TUBE
TRETINOIN tretinoin CREAM;TOPICAL 075264 ANDA Paddock Laboratories, LLC 0574-2225 0574-2225-45 1 TUBE in 1 CARTON (0574-2225-45) > 45 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.025%
Approval Date:Dec 24, 1998TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Dow
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Covington

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