An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021737
Company: BAUSCH AND LOMB

Products on NDA 021737

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RETISERT	FLUOCINOLONE ACETONIDE	0.59MG	IMPLANT;INTRAVITREAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021737

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/08/2005	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021737lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021737ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021737s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/04/2025	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021737s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021737Orig1s026ltr.pdf
03/30/2015	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
06/20/2014	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
06/02/2011	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021737s019.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021737s019ltr.pdf
11/30/2010	SUPPL-18	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021737s018ltr.pdf
08/05/2008	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021737s010ltr.pdf
10/30/2007	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021737s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021737s007ltr.pdf

Labels for NDA 021737

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/04/2025	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021737s026lbl.pdf
06/02/2011	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021737s019.pdf
10/30/2007	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021737s007lbl.pdf
04/08/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021737lbl.pdf

Top