Details for New Drug Application (NDA): 065031

NDA 065031 describes BLEOMYCIN SULFATE, which is a drug marketed by Cipla, Fresenius Kabi Usa, Hikma, Hospira, Meitheal, Pharmachemie Bv, Teva Parenteral, and Teva Pharms Usa, and is included in eight NDAs. It is available from six suppliers. Additional details are available on the BLEOMYCIN SULFATE profile page.

The generic ingredient in BLEOMYCIN SULFATE is bleomycin sulfate. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bleomycin sulfate profile page.

Summary for 065031

Tradename:	BLEOMYCIN SULFATE
Applicant:	Hospira
Ingredient:	bleomycin sulfate
Patents:	0

Pharmacology for NDA: 065031

Medical Subject Heading (MeSH) Categories for 065031

Antibiotics, Antineoplastic

Suppliers and Packaging for NDA: 065031

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BLEOMYCIN SULFATE	bleomycin sulfate	INJECTABLE;INJECTION	065031	ANDA	Hospira, Inc.	0409-0323	0409-0323-20	1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0323-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
BLEOMYCIN SULFATE	bleomycin sulfate	INJECTABLE;INJECTION	065031	ANDA	Hospira, Inc.	0409-0332	0409-0332-20	1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0332-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 15 UNITS BASE/VIAL
Approval Date:	Mar 10, 2000	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 30 UNITS BASE/VIAL
Approval Date:	Mar 10, 2000	TE:	AP	RLD:	No

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