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TRETINOIN

ANDA

TRETINOIN | A217497 | AMNEAL PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: ATRALIN(TE code: AB)

API Supply Chain6 active DMFs4 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBHTRETINOIN

DMF 34561978

OLON SPATRETINOIN

DMF 74741988

AMCOL HEALTH AND BEAUTY SOLUTIONS INCTRETINOIN 4% IN POLY-POREr POLYMER (TRETINOIN IN ALLYL METHACRYLATES CROSSPOLYMER)

DMF 231862009

OLON SPATRETINOIN TYPE 2

DMF 251922011

BIOPHORE INDIA PHARMACEUTICALS PVT LTDTRETINOIN

DMF 269222013

CHONGQING HUAPONT PHARMACEUTICAL CO LTDTRETINOIN

DMF 273982013

DSM NUTRITIONAL PRODUCTS LTDInactiveTRETINOIN (ALL-TRANS-RETINDE, ACID)

DMF 77341988

SHANGHAI NO 6 PHARMACEUTICAL FACTORYInactiveTRETINOIN

DMF 79961989

HOFFMANN LA ROCHE INCInactiveTRETINOIN CAPSULES

DMF 85921990

RANBAXY LABORATORIES LTDInactiveTRETINOIN USP (NON STERILE BULK)

DMF 244202010

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 0.08%

0 patents0 exclusivities▴

GEL;TOPICAL | Approved: May 14, 2026

No patent or exclusivity listings for this strength.

Change History (1)

Recent changes detected for this application.

ADDED7/1/2026

Amneal's tretinoin product (NDA 217497, strength 001) was added to the FDA's approved drug products database.

New: New record