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AZELASTINE HYDROCHLORIDE

ANDA

AZELASTINE HYDROCHLORIDE | A202743 | 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
MEDA PHARMACEUTICALS INC. v. APOTEX INC. et al 3:2012cv00361 1 patentANDA 201846, 091556, 202743azelastine hydrochloride	D.N.J.	2012-01-19	Terminated 2014-06-23	—

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.

Products (1)

#001 — 0.2055MG/SPRAY

0 patents0 exclusivities▴

SPRAY, METERED;NASAL | Approved: May 8, 2014

No patent or exclusivity listings for this strength.