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): 204891
Company: ALEMBIC

Products on ANDA 204891

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 204891

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/11/2017	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204891Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 204891

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

Top