Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075643
Company: RUBICON RESEARCH

Products on ANDA 075643

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
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	2.5MG	TABLET;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075643

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/16/2000	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75643ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/07/2025	SUPPL-21	Labeling-Container/Carton Labels		Label is not available on this site.
08/29/2011	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
03/12/2008	SUPPL-9	Labeling		Label is not available on this site.
07/31/2001	SUPPL-2	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.

Therapeutic Equivalents for ANDA 075643

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	218303	MICRO LABS
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 RESEARCH
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	5MG	TABLET;ORAL	Prescription	No	AB	075474	TP ANDA HOLDINGS
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	5MG	TABLET;ORAL	Prescription	No	AB	078635	UNICHEM
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	5MG	TABLET;ORAL	Prescription	No	AB	219044	UNIQUE PHARM
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	218303	MICRO LABS
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 RESEARCH
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	10MG	TABLET;ORAL	Prescription	No	AB	075474	TP ANDA HOLDINGS
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	10MG	TABLET;ORAL	Prescription	No	AB	078635	UNICHEM
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	10MG	TABLET;ORAL	Prescription	No	AB	219044	UNIQUE PHARM
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	10MG	TABLET;ORAL	Prescription	No	AB	215680	ZYDUS LIFESCIENCES