Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040190
Company: ELITE LABS INC

Products on ANDA 040190

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 040190

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/30/1997	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-17	Labeling-Package Insert		Label is not available on this site.
11/08/2013	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
11/14/2002	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/02/1999	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/07/1999	SUPPL-2	Labeling		Label is not available on this site.
08/10/1998	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 040190

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