Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205017
Company: NUVO PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE;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
09/25/2014 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-2 Labeling-Package Insert

Label is not available on this site.

PHENTERMINE HYDROCHLORIDE

CAPSULE;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 CAPSULE;ORAL Prescription No AA 088023 TEVA
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE;ORAL Prescription No AA 040228 ELITE LABS INC
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE;ORAL Prescription No AA 202846 INVAGEN PHARMS
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE;ORAL Prescription No AA 040887 KVK TECH
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE;ORAL Prescription No AA 201961 LANNETT CO INC
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE;ORAL Prescription No AA 205017 NUVO PHARM

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