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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078470
Company: HIKMA

Products on ANDA 078470

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 078470

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/07/2008	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078470s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/24/2016	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
05/25/2011	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
11/24/2008	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 078470

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

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