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FDA NDA · NDA017955

RETIN-A

tretinoin

Sponsor: BAUSCH

APPLICATION
NDA017955
TYPE
NDA
ORIGINAL APPROVAL
1978-10-17
LATEST ACTION
2013-02-01
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

RETIN-A · ReferencePrescription
TRETINOIN 0.01% · GEL · TOPICAL

Approval history

2013-02-01Manufacturing (CMC) · Supplement 31 · standardAP
2002-06-10Labeling · Supplement 19 · standard — Label ↗AP
2002-06-10Labeling · Supplement 23 · standard — Letter ↗AP
2002-06-10Labeling · Supplement 20 · standard — Label ↗AP
2001-03-20Manufacturing (CMC) · Supplement 24 · standardAP
1999-01-25Manufacturing (CMC) · Supplement 22 · standardAP
1998-07-23Manufacturing (CMC) · Supplement 21 · standardAP
1992-01-24Manufacturing (CMC) · Supplement 16 · standardAP
1990-08-28Labeling · Supplement 13AP
1990-08-28Labeling · Supplement 12AP
1990-07-03Manufacturing (CMC) · Supplement 14 · standardAP
1989-12-01Manufacturing (CMC) · Supplement 11 · standardAP
1986-07-23Manufacturing (CMC) · Supplement 8 · standardAP
1985-06-11Manufacturing (CMC) · Supplement 9 · standardAP
1983-06-06Manufacturing (CMC) · Supplement 7 · standardAP
1982-12-06Labeling · Supplement 4AP
1981-07-29Manufacturing (CMC) · Supplement 5 · standardAP
1980-04-28Labeling · Supplement 3AP
1979-11-05Manufacturing (CMC) · Supplement 2 · standardAP
1979-07-03Manufacturing (CMC) · Supplement 1 · standardAP
1978-10-17Type 3 - New Dosage Form · Original · standardAP
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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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