Viewing data from:

TAZAROTENE

ANDA

TAZAROTENE | A215433 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: TAZORAC(TE code: AB)

API Supply Chain3 active DMFs4 inactive

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

ALIVUS LIFE SCIENCES LTDTAZAROTENE

DMF 214222008

PCASTAZAROTENE

DMF 251612011

OLON SPATAZAROTENE

DMF 296002015

CARDINAL HEALTH PTS LLCInactiveTAZAROTENE 1.5 MG AND 4.5 MG CAPSULES

DMF 168642003

BASF SEInactiveTAZAROTENE

DMF 190892006

WATSON PHARMA PRIVATE LTDInactiveTAZAROTENE

DMF 200632006

PIRAMAL HEALTHCARE CANADA LTDInactiveTAZAROTENE

DMF 248742011

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 28, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.05%

0 patents0 exclusivities▴

GEL;TOPICAL | Approved: Sep 13, 2022

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Cosette Pharmaceuticals updated its registered applicant name from "Cosette" to "Cosette Pharms NC" for Tazarotene NDA 215433.

Old: COSETTE

New: COSETTE PHARMS NC

MODIFIEDApplicant Full Name7/1/2026

Cosette Pharmaceuticals updated its legal entity name from Cosette Pharmaceuticals Inc to Cosette Pharmaceuticals NC Laboratories LLC for the Tazarotene NDA 215433.

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC