← FDA DRUG APPROVALS

FDA NDA · NDA017354

LOESTRIN FE 1/20

Sponsor: TEVA BRANDED PHARM

APPLICATION
NDA017354
TYPE
NDA
ORIGINAL APPROVAL
1973-04-30
LATEST ACTION
2023-01-04
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LOESTRIN FE 1/20 · 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ESTRADIOL 0.02MG, NORETHINDRONE ACETATE 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-28

Approval history

2023-01-04Labeling · Supplement 55 · standard — Letter ↗AP
2022-04-29Labeling · Supplement 54 · standard — Letter ↗AP
2017-08-09Labeling · Supplement 51 · standard — Label ↗AP
2016-01-14Manufacturing (CMC) · Supplement 48 · priorityAP
2014-09-26Manufacturing (CMC) · Supplement 47 · priorityAP
2014-08-01Manufacturing (CMC) · Supplement 46 · priorityAP
2014-07-31Manufacturing (CMC) · Supplement 45 · priority — Label ↗AP
2003-05-02Labeling · Supplement 44 · standard — Letter ↗AP
1999-11-24Labeling · Supplement 42 · standardAP
1999-03-31Labeling · Supplement 43 · standardAP
1999-01-08Labeling · Supplement 41 · standardAP
1998-01-16Labeling · Supplement 40 · standardAP
1997-11-20Manufacturing (CMC) · Supplement 39 · priorityAP
1997-07-28Manufacturing (CMC) · Supplement 37 · priorityAP
1997-07-28Manufacturing (CMC) · Supplement 38 · priorityAP
1996-03-08Labeling · Supplement 30AP
1996-03-08Labeling · Supplement 33 · standardAP
1995-07-07Manufacturing (CMC) · Supplement 36 · priorityAP
1994-06-27Manufacturing (CMC) · Supplement 34 · priorityAP
1994-06-02Manufacturing (CMC) · Supplement 35 · priorityAP
1994-03-07Manufacturing (CMC) · Supplement 32 · priorityAP
1993-07-09Manufacturing (CMC) · Supplement 31 · priorityAP
1991-04-22Labeling · Supplement 29AP
1989-05-17Manufacturing (CMC) · Supplement 28 · priorityAP
1988-09-13Labeling · Supplement 26AP
1988-03-16Manufacturing (CMC) · Supplement 27 · priorityAP
1986-10-22Manufacturing (CMC) · Supplement 25 · priorityAP
1986-06-04Labeling · Supplement 24AP
1985-09-17Manufacturing (CMC) · Supplement 22 · priorityAP
1984-10-22Labeling · Supplement 23AP
1982-11-18Manufacturing (CMC) · Supplement 21 · priorityAP
1981-04-09Labeling · Supplement 19AP
1978-06-14Manufacturing (CMC) · Supplement 16 · priorityAP
1977-11-22Labeling · Supplement 17AP
1977-02-08Manufacturing (CMC) · Supplement 14 · priorityAP
1977-02-08Manufacturing (CMC) · Supplement 13 · priorityAP
1975-11-11Labeling · Supplement 10AP
1973-04-30Type 3 - New Dosage Form · 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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