APPLICATION
ANDA040190
TYPE
ANDA
ORIGINAL APPROVAL
1997-05-30
LATEST ACTION
2017-05-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PHENTERMINE HYDROCHLORIDEPrescription
PHENTERMINE HYDROCHLORIDE 37.5MG · TABLET · ORAL
Approval history
2017-05-31Labeling · Supplement 17 · standardAP
2013-11-08Manufacturing (CMC) · Supplement 15AP
2002-11-14Manufacturing (CMC) · Supplement 4AP
1999-09-02Manufacturing (CMC) · Supplement 3AP
1999-05-07Labeling · Supplement 2AP
1998-08-10Labeling · Supplement 1AP
1997-05-30OriginalAP
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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