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OLOPATADINE HYDROCHLORIDE

ANDA

OLOPATADINE HYDROCHLORIDE | A203152 | USV PRIVATE LTD

1 strength0 unique patents0 unique exclusivities

API Supply Chain9 active DMFs4 inactive

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

CURIA SPAIN SAUOLOPATADINE HYDROCHLORIDE (PROCESS I)

DMF 195262006

INDOCO REMEDIES LTDOLOPATADINE HYDROCHLORIDE USP

DMF 241062010

USV PRIVATE LTDOLOPATADINE HYDROCHLORIDE USP

DMF 245422011

MSN LABORATORIES PRIVATE LTDOLOPATADINE HYDROCHLORIDE USP [ROUTE CODE - "OH"]

DMF 246242011

FIS FABBRICA ITALIANA SINTETICI SPAOLOPATADINE HYDROCHLORIDE

DMF 262972012

KYOWA PHARMA CHEMICAL CO LTDOLOPATADINE HYDROCHLORIDE DRUG SUBSTANCE

DMF 283892014

FDC LTDOLOPATADINE HYDROCHLORIDE USP

DMF 294642015

SUN PHARMACEUTICAL INDUSTRIES LTDOLOPATADINE HYDROCHLORIDE USP

DMF 298652015

ALIVUS LIFE SCIENCES LTDOLOPATADINE HYDROCHLORIDE USP

DMF 317612017

KYOWA KIRIN CO LTDInactiveOLOPATADINE HYDROCHLORIDE (KW 4679)

DMF 118011996

URQUIMA SAInactiveOLOPATADINE HYDROCHLORIDE

DMF 194172006

FIS FABBRICA ITALIANA SINTETICI SPAInactiveOLOPATADINE HYDROCHLORIDE

DMF 232402009

APOTEX PHARMACHEM INDIA PVT LTDInactiveOLOPATADINE HYDROCHLORIDE USP

DMF 271712013

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Dec 9, 2015	ORIG -1	View Letter (PDF)
Oct 29, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.1% BASE

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Dec 7, 2015

No patent or exclusivity listings for this strength.