← FDA DRUG APPROVALS

FDA NDA · NDA203667

MINASTRIN 24 FE

Sponsor: APIL

APPLICATION
NDA203667
TYPE
NDA
ORIGINAL APPROVAL
2013-05-08
LATEST ACTION
2023-06-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

MINASTRIN 24 FE · ReferenceDiscontinued
ETHINYL ESTRADIOL 0.02MG, NORETHINDRONE ACETATE 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2023-06-26Labeling · Supplement 12 · standard — Label ↗AP
2022-04-29Labeling · Supplement 14 · standard — Label ↗AP
2017-08-09Labeling · Supplement 9 · standard — Label ↗AP
2016-12-20Labeling · Supplement 7 · standard — Letter ↗AP
2016-08-01Manufacturing (CMC) · Supplement 6 · standardAP
2015-09-03Manufacturing (CMC) · Supplement 5 · standardAP
2014-12-05Labeling · Supplement 4 · standard — Letter ↗AP
2014-04-14Manufacturing (CMC) · Supplement 3 · standardAP
2013-11-19Manufacturing (CMC) · Supplement 1 · standardAP
2013-07-11Labeling · Supplement 2 · standard — Letter ↗AP
2013-05-08Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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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