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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078441
Company: IMPAX LABS

Products on ANDA 078441

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACARBOSE	ACARBOSE	25MG	TABLET;ORAL	Prescription	AB	No	No
ACARBOSE	ACARBOSE	50MG	TABLET;ORAL	Prescription	AB	No	No
ACARBOSE	ACARBOSE	100MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078441

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/14/2009	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 078441

ACARBOSE

TABLET;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACARBOSE	ACARBOSE	25MG	TABLET;ORAL	Prescription	No	AB	202271	AVET LIFESCIENCES
ACARBOSE	ACARBOSE	25MG	TABLET;ORAL	Prescription	No	AB	078470	HIKMA
ACARBOSE	ACARBOSE	25MG	TABLET;ORAL	Prescription	No	AB	078441	IMPAX LABS
ACARBOSE	ACARBOSE	25MG	TABLET;ORAL	Prescription	No	AB	091343	SOMERSET THERAPS LLC
ACARBOSE	ACARBOSE	25MG	TABLET;ORAL	Prescription	No	AB	090912	STRIDES PHARMA
ACARBOSE	ACARBOSE	25MG	TABLET;ORAL	Prescription	No	AB	077532	WATSON LABS

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACARBOSE	ACARBOSE	50MG	TABLET;ORAL	Prescription	No	AB	202271	AVET LIFESCIENCES
ACARBOSE	ACARBOSE	50MG	TABLET;ORAL	Prescription	No	AB	078470	HIKMA
ACARBOSE	ACARBOSE	50MG	TABLET;ORAL	Prescription	No	AB	078441	IMPAX LABS
ACARBOSE	ACARBOSE	50MG	TABLET;ORAL	Prescription	No	AB	091343	SOMERSET THERAPS LLC
ACARBOSE	ACARBOSE	50MG	TABLET;ORAL	Prescription	No	AB	090912	STRIDES PHARMA
ACARBOSE	ACARBOSE	50MG	TABLET;ORAL	Prescription	No	AB	077532	WATSON LABS

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACARBOSE	ACARBOSE	100MG	TABLET;ORAL	Prescription	No	AB	202271	AVET LIFESCIENCES
ACARBOSE	ACARBOSE	100MG	TABLET;ORAL	Prescription	No	AB	078470	HIKMA
ACARBOSE	ACARBOSE	100MG	TABLET;ORAL	Prescription	No	AB	078441	IMPAX LABS
ACARBOSE	ACARBOSE	100MG	TABLET;ORAL	Prescription	No	AB	091343	SOMERSET THERAPS LLC
ACARBOSE	ACARBOSE	100MG	TABLET;ORAL	Prescription	No	AB	090912	STRIDES PHARMA
ACARBOSE	ACARBOSE	100MG	TABLET;ORAL	Prescription	No	AB	077532	WATSON LABS

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