← FDA DRUG APPROVALS

FDA NDA · NDA020713

MIRCETTE

Sponsor: TEVA BRANDED PHARM

APPLICATION
NDA020713
TYPE
NDA
ORIGINAL APPROVAL
1998-04-22
LATEST ACTION
2023-01-04
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

MIRCETTE · ReferenceDiscontinued
DESOGESTREL 0.15MG,N/A, ETHINYL ESTRADIOL 0.02MG,0.01MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-28

Approval history

2023-01-04Labeling · Supplement 13 · standard — Letter ↗AP
2022-04-29Labeling · Supplement 12 · standard — Label ↗AP
2017-08-09Labeling · Supplement 11 · standard — Label ↗AP
2012-07-18Labeling · Supplement 10 · standard — Label ↗AP
2002-03-08Manufacturing (CMC) · Supplement 8 · standardAP
2000-11-27Manufacturing (CMC) · Supplement 6 · standardAP
2000-10-03Labeling · Supplement 7 · standardAP
2000-08-30Manufacturing (CMC) · Supplement 5 · standardAP
2000-02-15Labeling · Supplement 4 · standardAP
1999-03-16Manufacturing (CMC) · Supplement 3 · standardAP
1998-11-19Manufacturing (CMC) · Supplement 2 · standardAP
1998-04-22Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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