Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091042
Company: KVK TECH

Products on ANDA 091042

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	35MG	TABLET;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091042

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/31/2010	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 091042

PHENDIMETRAZINE TARTRATE

TABLET;ORAL; 35MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BONTRIL PDM	PHENDIMETRAZINE TARTRATE	35MG	TABLET;ORAL	Prescription	Yes	AA	085272	BAUSCH
PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	35MG	TABLET;ORAL	Prescription	No	AA	085588	ACERTIS PHARMS
PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	35MG	TABLET;ORAL	Prescription	No	AA	089452	CHARTWELL
PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	35MG	TABLET;ORAL	Prescription	No	AA	040762	ELITE LABS INC
PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	35MG	TABLET;ORAL	Prescription	No	AA	091042	KVK TECH