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FDA NDA · NDA018932

REVIA

Sponsor: TEVA WOMENS

APPLICATION
NDA018932
TYPE
NDA
ORIGINAL APPROVAL
1984-11-20
LATEST ACTION
2013-10-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

REVIA · ReferenceDiscontinued
NALTREXONE HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2013-10-03Labeling · Supplement 17 · 901 required — Letter ↗AP
2001-05-15Labeling · Supplement 15 · standardAP
1999-03-05Labeling · Supplement 14 · standardAP
1999-03-05Labeling · Supplement 13 · standardAP
1995-06-23Manufacturing (CMC) · Supplement 12 · priorityAP
1994-12-30Efficacy · Supplement 10 · standardAP
1994-12-30Labeling · Supplement 11 · standardAP
1989-02-02Manufacturing (CMC) · Supplement 7 · priorityAP
1987-04-28Manufacturing (CMC) · Supplement 5 · priorityAP
1986-01-28Labeling · Supplement 3AP
1985-02-08Manufacturing (CMC) · Supplement 2 · priorityAP
1984-11-30Labeling · Supplement 1AP
1984-11-20Type 1 - New Molecular Entity · Original · priorityAP
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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