Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065031
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BLEOMYCIN SULFATE BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE;INJECTION Prescription AP No No
BLEOMYCIN SULFATE BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE;INJECTION 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
03/10/2000 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65031ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/20/2015 SUPPL-14 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

06/17/2013 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

06/07/2005 SUPPL-5 Labeling

Label is not available on this site.

05/14/2001 SUPPL-2 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

BLEOMYCIN SULFATE

INJECTABLE;INJECTION; EQ 15 UNITS BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BLEOMYCIN SULFATE BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE;INJECTION Prescription No AP 209439 CIPLA
BLEOMYCIN SULFATE BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065185 FRESENIUS KABI USA
BLEOMYCIN SULFATE BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065031 HOSPIRA
BLEOMYCIN SULFATE BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE;INJECTION Prescription No AP 205030 MEITHEAL
BLEOMYCIN SULFATE BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065033 TEVA PHARMS USA
BLEOMYCIN SULFATE BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065042 WEST-WARD PHARMS INT

INJECTABLE;INJECTION; EQ 30 UNITS BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BLEOMYCIN SULFATE BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065185 FRESENIUS KABI USA
BLEOMYCIN SULFATE BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065031 HOSPIRA
BLEOMYCIN SULFATE BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE;INJECTION Prescription No AP 205030 MEITHEAL
BLEOMYCIN SULFATE BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065033 TEVA PHARMS USA
BLEOMYCIN SULFATE BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065042 WEST-WARD PHARMS INT

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