← FDA DRUG APPROVALS

FDA NDA · NDA017856

TOPICORT

Sponsor: TARO

APPLICATION
NDA017856
TYPE
NDA
ORIGINAL APPROVAL
1977-02-28
LATEST ACTION
2004-04-27
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

TOPICORT · ReferenceDiscontinued
DESOXIMETASONE 0.25% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · TOPICAL

Approval history

2004-04-27Labeling · Supplement 24 — Label ↗AP
1998-09-15Manufacturing (CMC) · Supplement 30 · standardAP
1996-01-25Manufacturing (CMC) · Supplement 28 · standardAP
1994-07-26Manufacturing (CMC) · Supplement 27 · standardAP
1993-10-13Manufacturing (CMC) · Supplement 26 · standardAP
1988-11-08Manufacturing (CMC) · Supplement 22 · standardAP
1988-02-19Manufacturing (CMC) · Supplement 20 · standardAP
1986-09-25Manufacturing (CMC) · Supplement 19 · standardAP
1985-11-01Manufacturing (CMC) · Supplement 18 · standardAP
1983-11-07Manufacturing (CMC) · Supplement 16 · standardAP
1982-07-06Labeling · Supplement 10AP
1982-06-08Manufacturing (CMC) · Supplement 15 · standardAP
1981-08-20Manufacturing (CMC) · Supplement 13 · standardAP
1981-08-20Manufacturing (CMC) · Supplement 11 · standardAP
1981-08-20Manufacturing (CMC) · Supplement 12 · standardAP
1980-10-09Manufacturing (CMC) · Supplement 9 · standardAP
1979-10-23Manufacturing (CMC) · Supplement 7 · standardAP
1979-10-23Manufacturing (CMC) · Supplement 8 · standardAP
1979-10-23Manufacturing (CMC) · Supplement 6 · standardAP
1979-10-22Manufacturing (CMC) · Supplement 5 · standardAP
1979-07-23Manufacturing (CMC) · Supplement 4 · standardAP
1979-07-03Manufacturing (CMC) · Supplement 3 · standardAP
1978-06-30Labeling · Supplement 2AP
1977-10-21Manufacturing (CMC) · Supplement 1 · standardAP
1977-02-28Type 1 - New Molecular Entity · 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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