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AZELASTINE HYDROCHLORIDE ALLERGY

ANDA

AZELASTINE HYDROCHLORIDE | A216561 | AUROBINDO PHARMA LTD

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Bayer Healthcare LLC et al v. Aurobindo Pharma Ltd. et al 1:2021cv01575 3 patentsANDA 216561azelastine hydrochloride	D. Del.	2021-11-05	Terminated 2022-10-24	—

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

API Supply Chain8 active DMFs1 inactive

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

EVONIK OPERATIONS GMBHAZELASTINE HYDROCHLORIDE

DMF 154402001

DAITO PHARMACEUTICAL CO LTDAZELASTINE HYDROCHLORIDE DAITO USP

DMF 183982005

CURIA ITALY SRLAZELASTINE HYDROCHLORIDE

DMF 194222006

ESTEVE QUIMICA SAAZELASTINE HYDROCHLORIDE

DMF 224272009

ZYDUS LIFESCIENCES LTDAZELASTINE HYDROCHLORIDE

DMF 229192009

KOREA UNITED PHARMACEUTICALS INCAZELASTINE HYDROCHLORIDE

DMF 243172010

MSN LABORATORIES PRIVATE LTDAZELASTINE HYDROCHLORIDE USP [ROUTE CODE - "AH"]

DMF 253562011

CORAL DRUGS PRIVATE LTDAZELASTINE HYDROCHLORIDE USP

DMF 362052021

CIPLA LTDInactiveAZELASTINE HYDROCHLORIDE BP/PH.EUR

DMF 201862008

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Feb 24, 2025	ORIG -1	View Letter (PDF)
Feb 24, 2025	ORIG -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.2055MG/SPRAY

0 patents0 exclusivities▴

SPRAY, METERED;NASAL | Approved: Jan 27, 2025

No patent or exclusivity listings for this strength.