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Last Updated: June 23, 2024

Details for New Drug Application (NDA): 201687


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NDA 201687 describes TRETINOIN, which is a drug marketed by Barr Labs Inc, Endo Operations, Glenmark Pharms Ltd, Alembic, Allergan, Padagis Us, Taro, Zo Skin Health, Zydus Lifesciences, Mylan, Teva Pharms, Wockhardt, and Encube, and is included in twenty-two 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-six 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 201687
Tradename:TRETINOIN
Applicant:Endo Operations
Ingredient:tretinoin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201687
Medical Subject Heading (MeSH) Categories for 201687
Suppliers and Packaging for NDA: 201687
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRETINOIN tretinoin CAPSULE;ORAL 201687 ANDA Major Pharmaceuticals 0904-6867 0904-6867-04 30 BLISTER PACK in 1 CARTON (0904-6867-04) / 1 CAPSULE in 1 BLISTER PACK
TRETINOIN tretinoin CAPSULE;ORAL 201687 ANDA Par Pharmaceutical, Inc. 10370-268 10370-268-01 100 CAPSULE in 1 BOTTLE (10370-268-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Oct 24, 2012TE:ABRLD:No

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