Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 209406
Company: WATSON LABS INC

Products on ANDA 209406

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BRINZOLAMIDE	BRINZOLAMIDE	1%	SUSPENSION/DROPS;OPHTHALMIC	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209406

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/27/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209406Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/20/2022	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 209406

BRINZOLAMIDE

SUSPENSION/DROPS;OPHTHALMIC; 1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZOPT	BRINZOLAMIDE	1%	SUSPENSION/DROPS;OPHTHALMIC	Prescription	Yes	AB	020816	SANDOZ
BRINZOLAMIDE	BRINZOLAMIDE	1%	SUSPENSION/DROPS;OPHTHALMIC	Prescription	No	AB	204884	BAUSCH AND LOMB
BRINZOLAMIDE	BRINZOLAMIDE	1%	SUSPENSION/DROPS;OPHTHALMIC	Prescription	No	AB	211914	PADAGIS US
BRINZOLAMIDE	BRINZOLAMIDE	1%	SUSPENSION/DROPS;OPHTHALMIC	Prescription	No	AB	209406	WATSON LABS INC