Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 020475
Company: BAUSCH

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	AB	Yes	Yes

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/10/2025	SUPPL-29	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020475Orig1s029lbl.pdf
09/10/2025	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020475Orig1s029lbl.pdf
04/22/2025	SUPPL-36	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020475Orig1s036lbl.pdf
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