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FDA ANDA · ANDA087223

PHENTERMINE HYDROCHLORIDE

Sponsor: SANDOZ

APPLICATION
ANDA087223
TYPE
ANDA
ORIGINAL APPROVAL
1981-06-12
LATEST ACTION
1996-06-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

PHENTERMINE HYDROCHLORIDEDiscontinued
PHENTERMINE HYDROCHLORIDE 30MG · CAPSULE · ORAL

Approval history

1996-06-19Manufacturing (CMC) · Supplement 18AP
1996-04-12Manufacturing (CMC) · Supplement 20AP
1995-10-16Manufacturing (CMC) · Supplement 19AP
1994-12-21Manufacturing (CMC) · Supplement 14AP
1993-01-22Labeling · Supplement 17AP
1992-07-22Labeling · Supplement 16AP
1989-10-03Labeling · Supplement 13AP
1988-04-12Labeling · Supplement 12AP
1985-09-19Manufacturing (CMC) · Supplement 8AP
1985-01-30Manufacturing (CMC) · Supplement 9AP
1983-11-10Manufacturing (CMC) · Supplement 6AP
1983-09-02Manufacturing (CMC) · Supplement 5AP
1983-09-02Manufacturing (CMC) · Supplement 4AP
1982-02-03Manufacturing (CMC) · Supplement 1AP
1982-02-03Manufacturing (CMC) · Supplement 2AP
1981-06-12OriginalAP
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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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