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BRINZOLAMIDE

ANDA

BRINZOLAMIDE | A209406 | WATSON LABORATORIES INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: AZOPT(TE code: AB)

API Supply Chain11 active DMFs3 inactive

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

ICROM SRLBRINZOLAMIDE (MICRONIZED, MICRONIZED AND STERILE)

DMF 254782011

NEULAND LABORATORIES LTDBRINZOLAMIDE USP (STERILE)

DMF 269362013

INDOCO REMEDIES LTDBRINZOLAMIDE USP

DMF 281342014

BIOCON LTDBRINZOLAMIDE USP (STERILIZED)

DMF 289332015

SCI PHARMTECH INCBRINZOLAMIDE

DMF 297462015

DUKE CHEM SABRINZOLAMIDE MICRONIZED USP

DMF 322022018

PHARMATHEN SABRINZOLAMIDE

DMF 341672019

NEULAND LABORATORIES LTDBRINZOLAMIDE USP (PROCESS-II)

DMF 364522023

FDC LTDBRINZOLAMIDE USP

DMF 395122024

NEULAND LABORATORIES LTDBRINZOLAMIDE (PROCESS-II, STERILE)

DMF 399202024

MICRO LABS LTDBRINZOLAMIDE USP

DMF 405662024

VIWIT PHARMACEUTICAL CO LTDInactiveBRINZOLAMIDE USP

DMF 228512009

ALP PHARM BEIJING CO LTDInactiveBRINZOLAMIDE USP (DRUG SUBSTANCE, NON-STERILE)

DMF 237892010

BACHEM SAInactiveBRINZOLAMIDE

DMF 253242011

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 7, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

0 patents0 exclusivities▴

SUSPENSION/DROPS;OPHTHALMIC | Approved: Nov 27, 2020

No patent or exclusivity listings for this strength.