An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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	090912	STRIDES PHARMA
ACARBOSE	ACARBOSE	25MG	TABLET;ORAL	Prescription	No	AB	091343	VIRTUS PHARM
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	090912	STRIDES PHARMA
ACARBOSE	ACARBOSE	50MG	TABLET;ORAL	Prescription	No	AB	091343	VIRTUS PHARM
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	090912	STRIDES PHARMA
ACARBOSE	ACARBOSE	100MG	TABLET;ORAL	Prescription	No	AB	091343	VIRTUS PHARM
ACARBOSE	ACARBOSE	100MG	TABLET;ORAL	Prescription	No	AB	077532	WATSON LABS

Top