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Drugs@FDA: FDA-Approved Drugs

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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	AB	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
04/22/2025	SUPPL-36	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020475Orig1s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/020475Orig1s036ltr.pdf
09/10/2025	SUPPL-29	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020475s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020475Orig1s029ltr.pdf
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
09/10/2025	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020475s029lbl.pdf
09/10/2025	SUPPL-29	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020475s029lbl.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

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

GEL;TOPICAL; 0.06%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RETIN-A-MICRO	TRETINOIN	0.06%	GEL;TOPICAL	Prescription	Yes	AB	020475	BAUSCH
TRETINOIN MICROSPHERE	TRETINOIN	0.06%	GEL;TOPICAL	Prescription	No	AB	215609	ENCUBE

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