Viewing data from:

TAZAROTENE

ANDA

TAZAROTENE | A215393 | PADAGIS ISRAEL PHARMACEUTICALS LTD

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
BAUSCH HEALTH IRELAND LIMITED et al v. PADAGIS ISRAEL PHARMACEUTICALS LTD. et al 2:2022cv04248 1 patentANDA 215393tazarotene	D.N.J.	2022-06-24	Terminated 2024-05-07	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain4 active DMFs4 inactive

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

ALIVUS LIFE SCIENCES LTDTAZAROTENE

DMF 214222008

PCASTAZAROTENE

DMF 251612011

TARO PHARMACEUTICAL INDUSTRIES LTDTAZAROTENE, MICRONIZED

DMF 284702014

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
Jul 31, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.045%

0 patents0 exclusivities▴

LOTION;TOPICAL | Approved: Jul 29, 2025

No patent or exclusivity listings for this strength.