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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040715
Company: VINTAGE

Products on ANDA 040715

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	0.5MG	TABLET;ORAL	Prescription	AA	No	No
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	1MG	TABLET;ORAL	Prescription	AA	No	No
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	2MG	TABLET;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040715

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/27/2007	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 040715

BENZTROPINE MESYLATE

TABLET;ORAL; 0.5MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	0.5MG	TABLET;ORAL	Prescription	No	AA	204713	ASPEN GLOBAL INC
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	0.5MG	TABLET;ORAL	Prescription	No	AA	081265	CHARTWELL RX
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	0.5MG	TABLET;ORAL	Prescription	No	AA	072264	EPIC PHARMA LLC
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	0.5MG	TABLET;ORAL	Prescription	No	AA	090168	LEADING
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	0.5MG	TABLET;ORAL	Prescription	No	AA	089058	PLIVA
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	0.5MG	TABLET;ORAL	Prescription	No	AA	040715	VINTAGE

TABLET;ORAL; 1MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	1MG	TABLET;ORAL	Prescription	No	AA	204713	ASPEN GLOBAL INC
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	1MG	TABLET;ORAL	Prescription	No	AA	081265	CHARTWELL RX
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	1MG	TABLET;ORAL	Prescription	No	AA	072265	EPIC PHARMA LLC
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	1MG	TABLET;ORAL	Prescription	No	AA	090168	LEADING
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	1MG	TABLET;ORAL	Prescription	No	AA	089059	PLIVA
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	1MG	TABLET;ORAL	Prescription	No	AA	040715	VINTAGE

TABLET;ORAL; 2MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	2MG	TABLET;ORAL	Prescription	No	AA	204713	ASPEN GLOBAL INC
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	2MG	TABLET;ORAL	Prescription	No	AA	081265	CHARTWELL RX
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	2MG	TABLET;ORAL	Prescription	No	AA	072266	EPIC PHARMA LLC
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	2MG	TABLET;ORAL	Prescription	No	AA	090168	LEADING
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	2MG	TABLET;ORAL	Prescription	No	AA	089060	PLIVA
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	2MG	TABLET;ORAL	Prescription	No	AA	040715	VINTAGE

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