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Generated: August 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075213

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NDA 075213 describes TRETINOIN, which is a drug marketed by Allergan Sales Llc, Perrigo Pharma Intl, Mylan Pharms Inc, Wockhardt, Teva Pharms, Glenmark Pharms Ltd, Barr Labs Inc, Anchen Pharms, and Zo Skin Health, 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-five suppliers are listed for this compound. Additional details are available on the tretinoin profile page.

Summary for NDA: 075213

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

Pharmacology for NDA: 075213

Ingredient-typeRetinoids

Suppliers and Packaging for NDA: 075213

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRETINOIN
tretinoin
CREAM;TOPICAL 075213 ANDA Paddock Laboratories, LLC 0574-2201 0574-2201-20 1 TUBE in 1 CARTON (0574-2201-20) > 20 g in 1 TUBE
TRETINOIN
tretinoin
CREAM;TOPICAL 075213 ANDA Paddock Laboratories, LLC 0574-2201 0574-2201-45 1 TUBE in 1 CARTON (0574-2201-45) > 45 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.1%
Approval Date:Dec 24, 1998TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

McKinsey
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