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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089452
Company: CHARTWELL

Products on ANDA 089452

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 089452

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/30/1991	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
07/02/2013	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
08/13/2002	SUPPL-7	Manufacturing (CMC)-Facility		Label is not available on this site.
08/21/2001	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/13/1998	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
10/27/1998	SUPPL-4	Labeling		Label is not available on this site.
02/17/1998	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
02/17/1998	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
02/17/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 089452

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

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