APPLICATION
NDA017352
TYPE
NDA
ORIGINAL APPROVAL
1973-08-14
LATEST ACTION
1998-07-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
FASTINDiscontinued
PHENTERMINE HYDROCHLORIDE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
Approval history
1998-07-16Labeling · Supplement 19 · standardAP
1998-01-16Labeling · Supplement 18 · standardAP
1997-10-10Labeling · Supplement 17 · standardAP
1989-04-24Manufacturing (CMC) · Supplement 14 · standardAP
1984-07-31Manufacturing (CMC) · Supplement 11 · standardAP
1981-08-31Manufacturing (CMC) · Supplement 10 · standardAP
1981-08-31Manufacturing (CMC) · Supplement 9 · standardAP
1981-07-17Manufacturing (CMC) · Supplement 8 · standardAP
1980-09-26Manufacturing (CMC) · Supplement 7 · standardAP
1980-07-29Labeling · Supplement 6 · standardAP
1978-10-11Manufacturing (CMC) · Supplement 5 · standardAP
1977-02-02Manufacturing (CMC) · Supplement 4 · standardAP
1975-12-03Manufacturing (CMC) · Supplement 2 · standardAP
1975-07-22Manufacturing (CMC) · Supplement 3 · standardAP
1975-04-10Manufacturing (CMC) · Supplement 1 · standardAP
1973-08-14Type 3 - New Dosage Form · Original · standardAP
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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