FDA NDA · NDA019049

TRETINOIN CREAM

tretinoin

Sponsor: BAUSCH

APPLICATION

NDA019049

TYPE

NDA

ORIGINAL APPROVAL

1988-09-16

LATEST ACTION

2016-05-13

ROUTE

TOPICAL

DOSAGE FORM

CREAM

MARKETING STATUS

Prescription

Products

RETIN-A · ReferencePrescription

TRETINOIN 0.025% · CREAM · TOPICAL

2016-05-13Manufacturing (CMC) · Supplement 23 · standardAP

2013-01-08Manufacturing (CMC) · Supplement 21 · standardAP

2002-12-06Manufacturing (CMC) · Supplement 13 · standardAP

2002-06-10Labeling · Supplement 7 · standard — Label ↗AP

2002-06-10Labeling · Supplement 11 · standard — Letter ↗AP

2002-06-10Labeling · Supplement 8 · standard — Label ↗AP

2001-03-20Manufacturing (CMC) · Supplement 12 · standardAP

1999-01-25Manufacturing (CMC) · Supplement 10 · standardAP

1998-07-23Manufacturing (CMC) · Supplement 9 · standardAP

1992-01-24Manufacturing (CMC) · Supplement 5 · standardAP

1990-08-28Labeling · Supplement 2AP

1990-08-28Labeling · Supplement 3AP

1990-07-03Manufacturing (CMC) · Supplement 4 · standardAP

1989-12-01Manufacturing (CMC) · Supplement 1 · standardAP

1988-09-16Type 3 - New Dosage Form · Original · standardAP

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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