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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203068
Company: AUROLIFE PHARMA LLC

Products on ANDA 203068

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203068

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/06/2014	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, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 203068

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	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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