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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020816
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZOPT BRINZOLAMIDE 1% SUSPENSION/DROPS;OPHTHALMIC Prescription AB Yes Yes
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
06/22/2021 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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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 NOVARTIS
BRINZOLAMIDE BRINZOLAMIDE 1% SUSPENSION/DROPS;OPHTHALMIC Prescription No AB 204884 BAUSCH AND LOMB
BRINZOLAMIDE BRINZOLAMIDE 1% SUSPENSION/DROPS;OPHTHALMIC Prescription No AB 209406 WATSON LABS INC
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