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FDA NDA · NDA202088

SUPRENZA

Sponsor: CITIUS PHARMS

APPLICATION
NDA202088
TYPE
NDA
ORIGINAL APPROVAL
2011-06-13
LATEST ACTION
2014-02-18
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued

Products

SUPRENZADiscontinued
PHENTERMINE HYDROCHLORIDE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL
SUPRENZADiscontinued
PHENTERMINE HYDROCHLORIDE 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL
SUPRENZADiscontinued
PHENTERMINE HYDROCHLORIDE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2014-02-18Manufacturing (CMC) · Supplement 7 · standardAP
2013-07-11Labeling · Supplement 6 · unknown — Label ↗AP
2013-06-11Labeling · Supplement 5 · standard — Letter ↗AP
2012-12-05Labeling · Supplement 4 · 901 required — Label ↗AP
2012-03-27Labeling · Supplement 2 · standard — Letter ↗AP
2012-03-27Efficacy · Original · standardAP
2011-10-13Labeling · Supplement 1 · standard — Letter ↗AP
2011-06-13Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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