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FDA NDA · NDA204654

LO MINASTRIN FE

Sponsor: APIL

APPLICATION
NDA204654
TYPE
NDA
ORIGINAL APPROVAL
2013-07-24
LATEST ACTION
2017-08-09
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE, TABLET
MARKETING STATUS
Discontinued

Products

LO MINASTRIN FE · ReferenceDiscontinued
ETHINYL ESTRADIOL 0.01MG,0.01MG,N/A, NORETHINDRONE ACETATE 1MG,N/A,N/A · TABLET, CHEWABLE, TABLET · ORAL

Approval history

2017-08-09Labeling · Supplement 8 · standard — Label ↗AP
2017-06-28Labeling · Supplement 6 · standard — Letter ↗AP
2014-10-07Manufacturing (CMC) · Supplement 4 · standardAP
2014-05-20Manufacturing (CMC) · Supplement 3 · standardAP
2014-04-16Manufacturing (CMC) · Supplement 2 · standardAP
2013-07-24Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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