Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205962
Company: AUROBINDO PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BIVALIRUDIN BIVALIRUDIN 250MG/VIAL INJECTABLE;INTRAVENOUS Prescription AP 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
07/27/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205962TAltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/23/2019 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

BIVALIRUDIN

INJECTABLE;INTRAVENOUS; 250MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANGIOMAX BIVALIRUDIN 250MG/VIAL INJECTABLE;INTRAVENOUS Prescription Yes AP 020873 SANDOZ INC
BIVALIRUDIN BIVALIRUDIN 250MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 206551 ACCORD HLTHCARE
BIVALIRUDIN BIVALIRUDIN 250MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 205962 AUROBINDO PHARMA LTD
BIVALIRUDIN BIVALIRUDIN 250MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 091602 CIPLA
BIVALIRUDIN BIVALIRUDIN 250MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 201577 DR REDDYS LABS LTD
BIVALIRUDIN BIVALIRUDIN 250MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 090189 FRESENIUS KABI USA
BIVALIRUDIN BIVALIRUDIN 250MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 090811 HOSPIRA INC
BIVALIRUDIN BIVALIRUDIN 250MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 090816 HOSPIRA INC
BIVALIRUDIN BIVALIRUDIN 250MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 202471 MYLAN INSTITUTIONAL
BIVALIRUDIN BIVALIRUDIN 250MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 210031 SHUANGCHENG

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