Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206342
Company: POLYGEN PHARMS
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
11/18/2016 ORIG-1 Approval STANDARD

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-1 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 No 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 090470 BARR
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 040555 LANNETT
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET;ORAL Prescription No AA 091451 NOVAST LABS
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 206342 POLYGEN PHARMS
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 040790 SUN PHARM INDS INC
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET;ORAL Prescription No AA 040526 SUN PHARM INDUSTRIES

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