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FDA NDA · NDA016131

CLOMID

Sponsor: SANOFI AVENTIS US

APPLICATION
NDA016131
TYPE
NDA
ORIGINAL APPROVAL
1967-02-01
LATEST ACTION
2017-12-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CLOMID · ReferenceDiscontinued
CLOMIPHENE CITRATE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2017-12-18Labeling · Supplement 28 · standard — Label ↗AP
2012-10-22Labeling · Supplement 26 · standard — Letter ↗AP
2002-12-10Manufacturing (CMC) · Supplement 25 · priorityAP
1995-10-25Labeling · Supplement 24 · standardAP
1994-09-30Labeling · Supplement 23 · standardAP
1994-02-22Manufacturing (CMC) · Supplement 22 · priorityAP
1993-12-21Labeling · Supplement 17AP
1991-08-14Manufacturing (CMC) · Supplement 21 · priorityAP
1988-04-27Manufacturing (CMC) · Supplement 19 · priorityAP
1981-11-18Labeling · Supplement 15AP
1980-06-23Labeling · Supplement 10AP
1980-06-23Manufacturing (CMC) · Supplement 11 · priorityAP
1967-02-01Type 1 - New Molecular Entity · Original · priorityAP
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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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