← FDA DRUG APPROVALS

FDA ANDA · ANDA075256

RECLIPSEN 28 DAY

desogestrel and ethinyl estradiol

Sponsor: DURAMED PHARMS BARR

APPLICATION
ANDA075256
TYPE
ANDA
ORIGINAL APPROVAL
1999-08-12
LATEST ACTION
2022-04-29
ROUTE
ORAL-28, ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

DESOGESTREL AND ETHINYL ESTRADIOLPrescription
DESOGESTREL 0.15MG, ETHINYL ESTRADIOL 0.03MG · TABLET · ORAL-28
DESOGESTREL AND ETHINYL ESTRADIOLDiscontinued
DESOGESTREL 0.15MG, ETHINYL ESTRADIOL 0.03MG · TABLET · ORAL-21

Approval history

2022-04-29Labeling · Supplement 41 · standardAP
2017-08-09Labeling · Supplement 36 · standardAP
2016-05-26Labeling · Supplement 34 · standardAP
2015-04-13Labeling · Supplement 33 · standardAP
2013-01-31Labeling · Supplement 29 · standardAP
2004-11-26Labeling · Supplement 8AP
2002-06-19Manufacturing (CMC) · Supplement 7 — Label ↗AP
2001-11-14Manufacturing (CMC) · Supplement 3 — Letter ↗AP
2001-07-27Manufacturing (CMC) · Supplement 5 — Label ↗AP
2001-07-27Manufacturing (CMC) · Supplement 6 — Review ↗AP
2001-07-11Manufacturing (CMC) · Supplement 4 — Label ↗AP
2001-06-28Manufacturing (CMC) · Supplement 2 — Label ↗AP
1999-10-28Labeling · Supplement 1 — Label ↗AP
1999-08-12Original — Letter ↗AP
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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