Details for New Drug Application (NDA): 205030

NDA 205030 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 205030

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

Pharmacology for NDA: 205030

Medical Subject Heading (MeSH) Categories for 205030

Antibiotics, Antineoplastic

Suppliers and Packaging for NDA: 205030

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BLEOMYCIN SULFATE	bleomycin sulfate	INJECTABLE;INJECTION	205030	ANDA	NorthStar Rx LLC	16714-886	16714-886-01	1 VIAL, SINGLE-DOSE in 1 CARTON (16714-886-01) / 15 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
BLEOMYCIN SULFATE	bleomycin sulfate	INJECTABLE;INJECTION	205030	ANDA	NorthStar Rx LLC	16714-908	16714-908-01	1 VIAL, SINGLE-DOSE in 1 CARTON (16714-908-01) / 30 POWDER, 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:	Apr 20, 2018	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:	Apr 20, 2018	TE:	AP	RLD:	No

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