Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065185
Company: FRESENIUS KABI USA
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 Yes
BLEOMYCIN SULFATE BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE;INJECTION Prescription AP 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
01/28/2008 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
11/08/2011 SUPPL-3 Labeling-Container/Carton Labels

Label is not available on this site.

04/25/2011 SUPPL-2 Labeling-Package Insert

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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