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FDA NDA · NDA019190

TRIPHASIL-28

Sponsor: WYETH PHARMS INC

APPLICATION
NDA019190
TYPE
NDA
ORIGINAL APPROVAL
1984-11-01
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TRIPHASIL-28 · ReferenceDiscontinued
ETHINYL ESTRADIOL 0.03MG,0.04MG,0.03MG, LEVONORGESTREL 0.05MG,0.075MG,0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-28

Approval history

2022-04-29Labeling · Supplement 50 · standard — Label ↗AP
2019-05-08Labeling · Supplement 49 · standard — Letter ↗AP
2017-08-09Labeling · Supplement 48 · standard — Label ↗AP
2002-03-06Manufacturing (CMC) · Supplement 38 · standardAP
2000-03-23Labeling · Supplement 36 · standard — Label ↗AP
2000-02-02Labeling · Supplement 34 · standardAP
1998-12-11Manufacturing (CMC) · Supplement 35 · standardAP
1998-03-11Manufacturing (CMC) · Supplement 33 · standardAP
1997-08-25Manufacturing (CMC) · Supplement 32 · standardAP
1996-05-17Manufacturing (CMC) · Supplement 31 · standardAP
1995-10-11Manufacturing (CMC) · Supplement 30 · standardAP
1995-05-03Labeling · Supplement 29 · standardAP
1995-05-03Labeling · Supplement 28 · standardAP
1994-05-27Manufacturing (CMC) · Supplement 27 · standardAP
1994-04-08Manufacturing (CMC) · Supplement 26 · standardAP
1993-10-04Labeling · Supplement 25 · standardAP
1993-04-29Labeling · Supplement 23AP
1993-03-09Manufacturing (CMC) · Supplement 24 · standardAP
1992-06-10Manufacturing (CMC) · Supplement 22 · standardAP
1991-10-07Manufacturing (CMC) · Supplement 6 · standardAP
1991-08-15Manufacturing (CMC) · Supplement 14 · standardAP
1991-05-20Manufacturing (CMC) · Supplement 21 · standardAP
1991-05-03Manufacturing (CMC) · Supplement 20 · standardAP
1990-08-08Labeling · Supplement 12AP
1990-05-30Labeling · Supplement 19AP
1990-05-15Manufacturing (CMC) · Supplement 18 · standardAP
1990-01-18Manufacturing (CMC) · Supplement 17 · standardAP
1989-05-19Manufacturing (CMC) · Supplement 16 · standardAP
1988-04-27Manufacturing (CMC) · Supplement 13 · standardAP
1987-10-27Manufacturing (CMC) · Supplement 11 · standardAP
1987-05-15Manufacturing (CMC) · Supplement 9 · standardAP
1986-09-25Manufacturing (CMC) · Supplement 8 · standardAP
1986-07-15Labeling · Supplement 7AP
1986-05-28Manufacturing (CMC) · Supplement 4 · standardAP
1986-05-12Manufacturing (CMC) · Supplement 5 · standardAP
1985-12-20Labeling · Supplement 3AP
1985-09-06Labeling · Supplement 2AP
1985-07-29Manufacturing (CMC) · Supplement 1 · standardAP
1984-11-01Type 3 - New Dosage Form · Original · standardAP
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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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