Viewing data from:

BEXAROTENE

ANDA

BEXAROTENE | A215398 | AMNEAL PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: TARGRETIN(TE code: AB)

API Supply Chain7 active DMFs1 inactive

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

APICORE US LLCBEXAROTENE

DMF 236312010

REFARMED CHEMICALS LTDBEXAROTENE

DMF 255422011

HETERO LABS LTDBEXAROTENE

DMF 289442014

MSN LABORATORIES PRIVATE LTDBEXAROTENE [ROUTE CODE BX]

DMF 300772016

TIANJIN WEIJIE PHARMACEUTICAL CO LTDBEXAROTENE

DMF 315802017

EMCURE PHARMACEUTICALS LTDBEXAROTENE

DMF 319792017

SHANDONG ANHONG PHARMACEUTICAL CO LTDBEXAROTENE

DMF 424892025

USV LTDInactiveBEXAROTENE

DMF 235452010

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 26, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

0 patents0 exclusivities▴

GEL;TOPICAL | Approved: Apr 27, 2022

No patent or exclusivity listings for this strength.