Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204318
Company: AUROLIFE PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 15MG CAPSULE;ORAL Prescription AA No No
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG 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
11/09/2016 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-1 Labeling-Package Insert

Label is not available on this site.

PHENTERMINE HYDROCHLORIDE

CAPSULE;ORAL; 15MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 15MG CAPSULE;ORAL Prescription No AA 204318 AUROLIFE PHARMA LLC
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 15MG CAPSULE;ORAL Prescription No AA 090591 BARR
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 15MG CAPSULE;ORAL Prescription No AA 202248 ELITE LABS
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 15MG CAPSULE;ORAL Prescription No AA 202858 INVAGEN PHARMS
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 15MG CAPSULE;ORAL Prescription No AA 040886 KVK TECH
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 15MG CAPSULE;ORAL Prescription No AA 087022 LANNETT
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 15MG CAPSULE;ORAL Prescription No AA 205019 NUVO PHARM
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 15MG CAPSULE;ORAL Prescription No AA 087190 SANDOZ

CAPSULE;ORAL; 30MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AA 204318 AUROLIFE PHARMA LLC
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AA 090591 BARR
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AA 202248 ELITE LABS
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AA 202858 INVAGEN PHARMS
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AA 204414 INVAGEN PHARMS
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AA 040875 KVK TECH
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AA 040886 KVK TECH
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AA 087022 LANNETT
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AA 091359 LANNETT CO INC
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AA 205019 NUVO PHARM
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AA 086945 SANDOZ
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AA 087190 SANDOZ
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AA 040525 SUN PHARM INDUSTRIES

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