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FDA NDA · NDA018782

NORDETTE-28

Sponsor: TEVA BRANDED PHARM

APPLICATION
NDA018782
TYPE
NDA
ORIGINAL APPROVAL
1982-07-21
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

NORDETTE-28 · ReferenceDiscontinued
ETHINYL ESTRADIOL 0.03MG, LEVONORGESTREL 0.15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-28

Approval history

2022-04-29Labeling · Supplement 41 · standard — Label ↗AP
2021-05-07Labeling · Supplement 40 · standard — Letter ↗AP
2019-03-13Labeling · Supplement 39 · standard — Label ↗AP
2017-08-09Labeling · Supplement 38 · standard — Label ↗AP
2013-06-03Labeling · Supplement 36 · standard — Letter ↗AP
2002-03-06Manufacturing (CMC) · Supplement 27 · standardAP
2000-04-03Labeling · Supplement 23 · standard — Review ↗AP
1998-12-11Manufacturing (CMC) · Supplement 25 · standardAP
1998-03-11Manufacturing (CMC) · Supplement 24 · standardAP
1996-12-27Manufacturing (CMC) · Supplement 9 · standardAP
1996-05-17Manufacturing (CMC) · Supplement 22 · standardAP
1995-10-11Manufacturing (CMC) · Supplement 21 · standardAP
1994-11-29Labeling · Supplement 19 · standardAP
1994-04-08Manufacturing (CMC) · Supplement 20 · standardAP
1994-01-28Labeling · Supplement 18 · standardAP
1992-06-10Manufacturing (CMC) · Supplement 17 · standardAP
1991-05-20Manufacturing (CMC) · Supplement 15 · standardAP
1991-05-03Manufacturing (CMC) · Supplement 16 · standardAP
1990-08-08Labeling · Supplement 12AP
1989-05-19Manufacturing (CMC) · Supplement 14 · standardAP
1988-04-27Manufacturing (CMC) · Supplement 13 · standardAP
1986-07-15Labeling · Supplement 10AP
1986-02-19Manufacturing (CMC) · Supplement 7 · standardAP
1985-12-20Labeling · Supplement 8AP
1985-09-06Labeling · Supplement 6AP
1985-07-29Manufacturing (CMC) · Supplement 5 · standardAP
1985-03-12Manufacturing (CMC) · Supplement 2 · standardAP
1984-09-04Manufacturing (CMC) · Supplement 4 · standardAP
1984-07-25Labeling · Supplement 3AP
1982-12-03Labeling · Supplement 1AP
1982-07-21Type 5 - New Formulation or New Manufacturer · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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