← FDA DRUG APPROVALS

FDA NDA · NDA020946

PREVEN EMERGENCY CONTRACEPTIVE KIT

Sponsor: TEVA BRANDED PHARM

APPLICATION
NDA020946
TYPE
NDA
ORIGINAL APPROVAL
1998-09-01
LATEST ACTION
2002-11-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PREVEN EMERGENCY CONTRACEPTIVE KITDiscontinued
ETHINYL ESTRADIOL 0.05MG, LEVONORGESTREL 0.25MG · TABLET · ORAL

Approval history

2002-11-19Manufacturing (CMC) · Supplement 9 · priorityAP
2002-11-13Manufacturing (CMC) · Supplement 10 · priorityAP
2002-02-21Manufacturing (CMC) · Supplement 7 · priorityAP
2002-02-21Manufacturing (CMC) · Supplement 8 · priorityAP
2001-07-17Manufacturing (CMC) · Supplement 6 · priorityAP
2000-08-02Manufacturing (CMC) · Supplement 4 · priorityAP
2000-05-23Manufacturing (CMC) · Supplement 3 · priorityAP
2000-04-03Labeling · Supplement 5 · standardAP
2000-02-02Manufacturing (CMC) · Supplement 2 · priorityAP
1999-06-07Labeling · Supplement 1 · standard — Review ↗AP
1998-09-01Type 3 - New Dosage Form · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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