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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040797
Company: INVAGEN PHARMS

Products on ANDA 040797

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MEPROBAMATE	MEPROBAMATE	200MG	TABLET;ORAL	Prescription	AA	No	No
MEPROBAMATE	MEPROBAMATE	400MG	TABLET;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040797

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/27/2008	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 040797

MEPROBAMATE

TABLET;ORAL; 200MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEPROBAMATE	MEPROBAMATE	200MG	TABLET;ORAL	Prescription	No	AA	090122	ALEMBIC PHARMS LTD
MEPROBAMATE	MEPROBAMATE	200MG	TABLET;ORAL	Prescription	No	AA	040797	INVAGEN PHARMS

TABLET;ORAL; 400MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEPROBAMATE	MEPROBAMATE	400MG	TABLET;ORAL	Prescription	No	AA	090122	ALEMBIC PHARMS LTD
MEPROBAMATE	MEPROBAMATE	400MG	TABLET;ORAL	Prescription	No	AA	040797	INVAGEN PHARMS

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