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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077910
Company: AUROBINDO PHARMA

Products on ANDA 077910

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	5MG	TABLET;ORAL	Prescription	AB	No	No
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	10MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077910

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/27/2006	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/29/2011	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
12/13/2007	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077910

BISOPROLOL FUMARATE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	5MG	TABLET;ORAL	Prescription	No	AB	204891	ALEMBIC
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	5MG	TABLET;ORAL	Prescription	No	AB	077910	AUROBINDO PHARMA
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	5MG	TABLET;ORAL	Prescription	No	AB	217617	HARMAN FINOCHEM
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	5MG	TABLET;ORAL	Prescription	No	AB	215563	NOVITIUM PHARMA
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	5MG	TABLET;ORAL	Prescription	No	AB	217368	PRINSTON INC
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	5MG	TABLET;ORAL	Prescription	No	AB	075643	RUBICON
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	5MG	TABLET;ORAL	Prescription	No	AB	078635	UNICHEM
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	5MG	TABLET;ORAL	Prescription	No	AB	075474	UNITED RES LABS
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	5MG	TABLET;ORAL	Prescription	No	AB	215680	ZYDUS LIFESCIENCES

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	10MG	TABLET;ORAL	Prescription	No	AB	204891	ALEMBIC
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	10MG	TABLET;ORAL	Prescription	No	AB	077910	AUROBINDO PHARMA
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	10MG	TABLET;ORAL	Prescription	No	AB	217617	HARMAN FINOCHEM
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	10MG	TABLET;ORAL	Prescription	No	AB	215563	NOVITIUM PHARMA
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	10MG	TABLET;ORAL	Prescription	No	AB	217368	PRINSTON INC
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	10MG	TABLET;ORAL	Prescription	No	AB	075643	RUBICON
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	10MG	TABLET;ORAL	Prescription	No	AB	078635	UNICHEM
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	10MG	TABLET;ORAL	Prescription	No	AB	075474	UNITED RES LABS
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	10MG	TABLET;ORAL	Prescription	No	AB	215680	ZYDUS LIFESCIENCES

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