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BISOPROLOL FUMARATE از شرکت UNICHEM

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BISOPROLOL FUMARATE از شرکت UNICHEM

Abbreviated New Drug Application (ANDA): 078635

Company: UNICHEM

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 Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/18/2009 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
08/07/2019 SUPPL-17 Labeling-Container/Carton Labels

Label is not available on this site.

08/19/2016 SUPPL-8 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

05/26/2015 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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 LABS
BISOPROLOL FUMARATE BISOPROLOL FUMARATE 5MG TABLET;ORAL Prescription No AB 077910 AUROBINDO PHARMA
BISOPROLOL FUMARATE BISOPROLOL FUMARATE 5MG TABLET;ORAL Prescription No AB 075474 FRONTIDA BIOPHARM
BISOPROLOL FUMARATE BISOPROLOL FUMARATE 5MG TABLET;ORAL Prescription No AB 215563 NOVITIUM PHARMA
BISOPROLOL FUMARATE BISOPROLOL FUMARATE 5MG TABLET;ORAL Prescription No AB 075643 RUBICON
BISOPROLOL FUMARATE BISOPROLOL FUMARATE 5MG TABLET;ORAL Prescription No AB 078635 UNICHEM

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 LABS
BISOPROLOL FUMARATE BISOPROLOL FUMARATE 10MG TABLET;ORAL Prescription No AB 077910 AUROBINDO PHARMA
BISOPROLOL FUMARATE BISOPROLOL FUMARATE 10MG TABLET;ORAL Prescription No AB 075474 FRONTIDA BIOPHARM
BISOPROLOL FUMARATE BISOPROLOL FUMARATE 10MG TABLET;ORAL Prescription No AB 215563 NOVITIUM PHARMA
BISOPROLOL FUMARATE BISOPROLOL FUMARATE 10MG TABLET;ORAL Prescription No AB 075643 RUBICON
BISOPROLOL FUMARATE BISOPROLOL FUMARATE 10MG TABLET;ORAL Prescription No AB 078635 UNICHEM
بخوانید  BISOPROLOL FUMARATE از شرکت FRONTIDA BIOPHARM
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