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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065031
Company: HOSPIRA

Products on ANDA 065031

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065031

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-Container/Carton Labels, Labeling-Package Insert		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.

Therapeutic Equivalents for ANDA 065031

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	065185	FRESENIUS KABI USA
BLEOMYCIN SULFATE	BLEOMYCIN SULFATE	EQ 15 UNITS BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065042	HIKMA
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

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	065042	HIKMA
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

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