← FDA DRUG APPROVALS

FDA NDA · NDA020475

RETIN-A MICRO

tretinoin

Sponsor: BAUSCH

APPLICATION
NDA020475
TYPE
NDA
ORIGINAL APPROVAL
1997-02-07
LATEST ACTION
2025-09-10
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

RETIN-A-MICRO · ReferencePrescription
TRETINOIN 0.06% · GEL · TOPICAL
RETIN-A MICRO · ReferencePrescription
TRETINOIN 0.04% · GEL · TOPICAL
RETIN-A-MICRO · ReferencePrescription
TRETINOIN 0.08% · GEL · TOPICAL
RETIN-A MICRO · ReferencePrescription
TRETINOIN 0.1% · GEL · TOPICAL

Approval history

2025-09-10Labeling · Supplement 29 · standard — Letter ↗AP
2025-04-22Manufacturing (CMC) · Supplement 36 — Label ↗AP
2014-08-21Manufacturing (CMC) · Supplement 24 · standardAP
2014-01-29Manufacturing (CMC) · Supplement 23 · standardAP
2014-01-28Manufacturing (CMC) · Supplement 21 · standard — Review ↗AP
2013-01-08Manufacturing (CMC) · Supplement 20 · standardAP
2009-02-26Manufacturing (CMC) · Supplement 13AP
2002-05-10Efficacy · Supplement 8 · standard — Letter ↗AP
2001-03-20Manufacturing (CMC) · Supplement 7 · standardAP
2000-04-27Labeling · Supplement 6 · standardAP
2000-04-05Manufacturing (CMC) · Supplement 5 · standardAP
1999-11-10Manufacturing (CMC) · Supplement 4 · standardAP
1999-04-23Manufacturing (CMC) · Supplement 3 · standardAP
1998-11-13Manufacturing (CMC) · Supplement 1 · standardAP
1998-11-13Manufacturing (CMC) · Supplement 2 · standardAP
1997-02-07Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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