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OXYMETAZOLINE HYDROCHLORIDE

ANDA

OXYMETAZOLINE HYDROCHLORIDE | A213584 | SUN PHARMA CANADA INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: RHOFADE(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
EPI Health, LLC et al v. Taro Pharmaceuticals, Inc. 1:2019cv01910 5 patentsANDA 213584oxymetazoline HCl (oxymetazoline)	D. Del.	2019-10-08	Terminated 2021-05-24	—

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

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBHOXYMETAZOLINE HYDROCHLORIDE

DMF 89401991

CTX LIFE SCIENCES PVT LTDOXYMETAZOLINE HYDROCHLORIDE USP

DMF 224012008

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 20, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Oct 4, 2021

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDtype7/1/2026

Sun Pharma Canada's oxymetazoline hydrochloride product (NDA 213584) transitioned from discontinued status to an active prescription drug product.

Old: DISCN

New: RX

MODIFIEDTE Code7/1/2026

Sun Pharma Canada's oxymetazoline hydrochloride (NDA 213584) received an AB therapeutic equivalence rating, indicating bioequivalence to the reference product.

New: AB