← FDA DRUG APPROVALS

FDA NDA · NDA021040

PREFEST

Sponsor: TEVA WOMENS

APPLICATION
NDA021040
TYPE
NDA
ORIGINAL APPROVAL
1999-10-22
LATEST ACTION
2024-02-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PREFEST · ReferenceDiscontinued
ESTRADIOL 1MG,1MG, NORGESTIMATE N/A,0.09MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2024-02-15Labeling · Supplement 15 · standard — Letter ↗AP
2017-11-01Labeling · Supplement 13 · standard — Label ↗AP
2004-07-13Labeling · Supplement 12 · standard — Letter ↗AP
2003-12-19Labeling · Supplement 7 · standard — Label ↗AP
2003-12-19Labeling · Supplement 5 · standard — Letter ↗AP
2003-12-19Labeling · Supplement 1 · standard — Letter ↗AP
2003-12-19Labeling · Supplement 2 · standard — Letter ↗AP
2003-12-19Labeling · Supplement 9 · standard — Letter ↗AP
2003-01-23Labeling · Supplement 10 · standard — Letter ↗AP
2002-11-13Manufacturing (CMC) · Supplement 11 · standardAP
2001-10-30Labeling · Supplement 8 · standardAP
2001-01-18Manufacturing (CMC) · Supplement 6 · standardAP
2000-11-06Manufacturing (CMC) · Supplement 3 · standardAP
1999-10-22Type 4 - New Combination · Original · standard — Letter ↗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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