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Generated: May 25, 2017

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Details for New Drug Application (NDA): 075589

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NDA 075589 describes TRETINOIN, which is a drug marketed by Allergan Sales Llc, Perrigo Pharma Intl, Spear Pharms Inc, Wockhardt, Teva Pharms, Glenmark Generics, Barr Labs Inc, Anchen Pharms, and Zo Skin Health, and is included in sixteen NDAs. It is available from nineteen 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 NDA: 075589

Therapeutic Class:Antineoplastics
Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075589


Suppliers and Packaging for NDA: 075589

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GEL;TOPICAL 075589 ANDA Paddock Laboratories, LLC 0574-2301 0574-2301-45 1 TUBE in 1 CARTON (0574-2301-45) > 45 g in 1 TUBE
GEL;TOPICAL 075589 ANDA Rouses Point Pharm 43478-245 43478-245-15 1 TUBE in 1 CARTON (43478-245-15) > 15 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.01%
Approval Date:Jun 11, 2002TE:ABRLD:No

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