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): 020475
Company: BAUSCH

Products on NDA 020475

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RETIN-A MICRO	TRETINOIN	0.1%	GEL;TOPICAL	Prescription	None	Yes	Yes
RETIN-A MICRO	TRETINOIN	0.04%	GEL;TOPICAL	Prescription	None	Yes	Yes
RETIN-A-MICRO	TRETINOIN	0.08%	GEL;TOPICAL	Prescription	AB	Yes	Yes
RETIN-A-MICRO	TRETINOIN	0.06%	GEL;TOPICAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020475

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/07/1997	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020475ap.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/21/2014	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
01/29/2014	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
01/28/2014	SUPPL-21	Manufacturing (CMC)	Label (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020475s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/020475Org1s021.pdf
01/08/2013	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
02/26/2009	SUPPL-13	Labeling-Container/Carton Labels		Label is not available on this site.
05/10/2002	SUPPL-8	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20475s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20475s008ltr.pdf
03/20/2001	SUPPL-7	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/27/2000	SUPPL-6	Labeling		Label is not available on this site.
04/05/2000	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
11/10/1999	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/23/1999	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
11/13/1998	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
11/13/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 020475

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/28/2014	SUPPL-21	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020475s021lbl.pdf
05/10/2002	SUPPL-8	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20475s8lbl.pdf

Therapeutic Equivalents for NDA 020475

RETIN-A MICRO

There are no Therapeutic Equivalents.

RETIN-A-MICRO

GEL;TOPICAL; 0.08%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RETIN-A-MICRO	TRETINOIN	0.08%	GEL;TOPICAL	Prescription	Yes	AB	020475	BAUSCH
TRETINOIN MICROSPHERE	TRETINOIN	0.08%	GEL;TOPICAL	Prescription	No	AB	215609	ENCUBE

Top