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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020816
Company: SANDOZ

Products on NDA 020816

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AZOPT	BRINZOLAMIDE	1%	SUSPENSION/DROPS;OPHTHALMIC	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020816

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/01/1998	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20816lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20816ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020816_azopt.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/28/2023	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020816s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020816Orig1s025ltr.pdf
06/22/2021	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020816s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020816Orig1s023ltr.pdf
11/10/2015	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020816s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020816Orig1s019ltr.pdf
03/08/2011	SUPPL-12	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020816s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020816s012ltr.pdf
09/28/2006	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020816s009LTR.pdf
07/22/2003	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20816slr006_azopt_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20816slr006ltr.pdf
07/12/2002	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
10/16/2001	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
06/02/2000	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/17/1999	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
02/05/1999	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 020816

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/28/2023	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020816s025lbl.pdf
06/22/2021	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020816s023lbl.pdf
11/10/2015	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020816s019lbl.pdf
03/08/2011	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020816s012lbl.pdf
07/22/2003	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20816slr006_azopt_lbl.pdf
04/01/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20816lbl.pdf

Therapeutic Equivalents for NDA 020816

AZOPT

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

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