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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218303
Company: MICRO LABS

Products on ANDA 218303

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 218303

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/09/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218303

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

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