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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040526
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET;ORAL Prescription AA No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/23/2003 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/31/2017 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

12/06/2012 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

05/23/2012 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

04/23/2013 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

PHENTERMINE HYDROCHLORIDE

TABLET;ORAL; 37.5MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADIPEX-P PHENTERMINE HYDROCHLORIDE 37.5MG TABLET;ORAL Prescription Yes AA 085128 TEVA
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET;ORAL Prescription No AA 203068 AUROLIFE PHARMA LLC
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET;ORAL Prescription No AA 200272 ELITE LABS
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET;ORAL Prescription No AA 040190 ELITE LABS INC
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET;ORAL Prescription No AA 202942 INVAGEN PHARMS
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET;ORAL Prescription No AA 040876 KVK TECH
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET;ORAL Prescription No AA 206342 MERRO PHARM USA
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET;ORAL Prescription No AA 205008 NUVO PHARM
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET;ORAL Prescription No AA 040377 PRINSTON INC
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET;ORAL Prescription No AA 040526 SUN PHARM INDUSTRIES
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