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FDA ANDA · ANDA088023

ADIPEX-P

Sponsor: TEVA

APPLICATION
ANDA088023
TYPE
ANDA
ORIGINAL APPROVAL
1983-08-02
LATEST ACTION
2017-05-31
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

ADIPEX-P · ReferenceDiscontinued
PHENTERMINE HYDROCHLORIDE 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2017-05-31Labeling · Supplement 43 · standardAP
2013-01-07Labeling · Supplement 38 · standardAP
2012-04-16Labeling · Supplement 37 — Label ↗AP
2002-10-15Manufacturing (CMC) · Supplement 33AP
2000-07-07Manufacturing (CMC) · Supplement 32AP
1998-11-12Labeling · Supplement 31AP
1998-03-09Manufacturing (CMC) · Supplement 30AP
1997-12-16Labeling · Supplement 29AP
1997-08-29Labeling · Supplement 28AP
1997-08-29Manufacturing (CMC) · Supplement 26AP
1997-08-29Manufacturing (CMC) · Supplement 27AP
1997-08-29Manufacturing (CMC) · Supplement 25AP
1996-02-13Manufacturing (CMC) · Supplement 21AP
1996-01-25Manufacturing (CMC) · Supplement 24AP
1996-01-25Manufacturing (CMC) · Supplement 22AP
1996-01-25Manufacturing (CMC) · Supplement 23AP
1995-03-02Manufacturing (CMC) · Supplement 20AP
1994-01-26Manufacturing (CMC) · Supplement 18AP
1994-01-26Manufacturing (CMC) · Supplement 16AP
1994-01-26Manufacturing (CMC) · Supplement 14AP
1994-01-26Manufacturing (CMC) · Supplement 19AP
1994-01-26Manufacturing (CMC) · Supplement 17AP
1994-01-26Manufacturing (CMC) · Supplement 15AP
1993-05-25Manufacturing (CMC) · Supplement 12AP
1993-05-25Manufacturing (CMC) · Supplement 13AP
1993-05-25Manufacturing (CMC) · Supplement 11AP
1993-04-01Manufacturing (CMC) · Supplement 10AP
1988-12-23Labeling · Supplement 9AP
1987-11-12Manufacturing (CMC) · Supplement 4AP
1987-11-12Manufacturing (CMC) · Supplement 7AP
1987-11-12Manufacturing (CMC) · Supplement 5AP
1987-11-12Manufacturing (CMC) · Supplement 3AP
1983-12-30Manufacturing (CMC) · Supplement 2AP
1983-11-22Manufacturing (CMC) · Supplement 1AP
1983-08-02OriginalAP
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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