Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040228
Company: ELITE LABS INC

Products on ANDA 040228

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040228

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/19/1997	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-12	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 040228

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
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	040887	KVK TECH
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE;ORAL	Prescription	No	AA	205017	NUVO PHARM