Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075643
Company: CASI PHARMS INC
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
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
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.

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 077910 AUROBINDO PHARMA
BISOPROLOL FUMARATE BISOPROLOL FUMARATE 5MG TABLET;ORAL Prescription No AB 075643 CASI PHARMS INC
BISOPROLOL FUMARATE BISOPROLOL FUMARATE 5MG TABLET;ORAL Prescription No AB 075474 FRONTIDA BIOPHARM
BISOPROLOL FUMARATE BISOPROLOL FUMARATE 5MG TABLET;ORAL Prescription No AB 204891 ORIT LABS LLC
BISOPROLOL FUMARATE BISOPROLOL FUMARATE 5MG TABLET;ORAL Prescription No AB 078635 UNICHEM PHARMS (USA)

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 077910 AUROBINDO PHARMA
BISOPROLOL FUMARATE BISOPROLOL FUMARATE 10MG TABLET;ORAL Prescription No AB 075643 CASI PHARMS INC
BISOPROLOL FUMARATE BISOPROLOL FUMARATE 10MG TABLET;ORAL Prescription No AB 075474 FRONTIDA BIOPHARM
BISOPROLOL FUMARATE BISOPROLOL FUMARATE 10MG TABLET;ORAL Prescription No AB 204891 ORIT LABS LLC
BISOPROLOL FUMARATE BISOPROLOL FUMARATE 10MG TABLET;ORAL Prescription No AB 078635 UNICHEM PHARMS (USA)

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