APPLICATION
ANDA040526
TYPE
ANDA
ORIGINAL APPROVAL
2003-10-23
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 18 · standardAP
2013-04-23Manufacturing (CMC) · Supplement 11AP
2012-12-06Labeling · Supplement 13 · standardAP
2012-05-23Labeling · Supplement 12 · standardAP
2003-10-23OriginalAP
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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