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FDA NDA · NDA016921

RETIN-A

Sponsor: VALEANT INTL

APPLICATION
NDA016921
TYPE
NDA
ORIGINAL APPROVAL
1971-10-20
LATEST ACTION
2002-06-10
ROUTE
TOPICAL
DOSAGE FORM
SWAB, SOLUTION
MARKETING STATUS
Discontinued

Products

RETIN-ADiscontinued
TRETINOIN 0.05% · SWAB · TOPICAL
RETIN-A · ReferenceDiscontinued
TRETINOIN 0.05% · SOLUTION · TOPICAL

Approval history

2002-06-10Labeling · Supplement 22 · standard — Label ↗AP
2002-06-10Labeling · Supplement 25 · standard — Label ↗AP
2002-06-10Labeling · Supplement 21 · standard — Letter ↗AP
1999-01-25Manufacturing (CMC) · Supplement 24 · priorityAP
1998-07-23Manufacturing (CMC) · Supplement 23 · priorityAP
1992-01-24Manufacturing (CMC) · Supplement 20 · priorityAP
1990-08-28Labeling · Supplement 19AP
1986-07-22Manufacturing (CMC) · Supplement 17 · priorityAP
1983-06-06Manufacturing (CMC) · Supplement 16 · priorityAP
1982-12-13Labeling · Supplement 14AP
1981-07-28Manufacturing (CMC) · Supplement 15 · priorityAP
1980-04-28Labeling · Supplement 13AP
1979-10-24Manufacturing (CMC) · Supplement 12 · priorityAP
1978-12-04Labeling · Supplement 11AP
1977-01-04Labeling · Supplement 10AP
1974-09-20Manufacturing (CMC) · Supplement 9 · priorityAP
1971-10-20Type 1 - New Molecular Entity · Original · priorityAP
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