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DORZOLAMIDE HYDROCHLORIDE

ANDA

DORZOLAMIDE HYDROCHLORIDE | A202053 | REGCON HOLDINGS LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain11 active DMFs7 inactive

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

CURIA SPAIN SAUDORZOLAMIDE HYDROCHLORIDE

DMF 183852005

NEULAND LABORATORIES LTDDORZOLAMIDE HYDROCHLORIDE FORM II USP

DMF 215192008

INDOCO REMEDIES LTDDORZOLAMIDE HYDROCHLORIDE USP

DMF 237952010

MICRO LABS LTDDORZOLAMIDE HYDROCHLORIDE USP

DMF 247532011

HETERO DRUGS LTDDORZOLAMIDE HYDROCHLORIDE (PROCESS II)

DMF 262042012

FIS FABBRICA ITALIANA SINTETICI SPADORZOLAMIDE HYDROCHLORIDE (ALTERNATIVE PROCESS)

DMF 295842015

NEULAND LABORATORIES LTDDORZOLAMIDE HYDROCHLORIDE USP (PROCESS-II)

DMF 330242018

FDC LTDDORZOLAMIDE HYDROCHLORIDE USP (PROCESS II)

DMF 335762019

CENTURY PHARMACEUTICALS LTDDORZOLAMIDE HYDROCHLORIDE USP

DMF 347972020

GLOBAL CALCIUM PRIVATE LTDDORZOLAMIDE HYDROCHLORIDE USP

DMF 396292024

SHOBHA LIFE SCIENCES PRIVATE LIMITEDDORZOLAMIDE HYDROCHLORIDE USP

DMF 416442025

USV LTDInactiveDORZOLAMIDE HYDROCHLORIDE USP

DMF 202842007

FIS FABBRICA ITALIANA SINTETICI SPAInactiveDORZOLAMIDE HYDROCHLORIDE

DMF 207402007

FDC LTDInactiveDORZOLAMIDE HYDROCHLORIDE USP

DMF 208562007

PCASInactiveDORZOLAMIDE HYDROCHLORIDE

DMF 213492008

ZACH SYSTEM SPAInactiveDORZOLAMIDE HYDROCHLORIDE

DMF 216262008

HETERO DRUGS LTDInactiveDORZOLAMIDE HYDROCHLORIDE ( PROCESS I )

DMF 219102008

BACHEM SAInactiveDORZOLAMIDE HYDROCHLORIDE

DMF 233852009

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 16, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 2% BASE

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Sep 11, 2014

No patent or exclusivity listings for this strength.