Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090122
Company: ALEMBIC PHARMS LTD

Products on ANDA 090122

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090122

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/18/2009	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 090122

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