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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 209439

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NDA 209439 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 209439

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

Pharmacology for NDA: 209439

Medical Subject Heading (MeSH) Categories for 209439

Antibiotics, Antineoplastic

Suppliers and Packaging for NDA: 209439

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BLEOMYCIN SULFATE	bleomycin sulfate	INJECTABLE;INJECTION	209439	ANDA	Cipla USA Inc.	69097-364	69097-364-36	1 VIAL in 1 CARTON (69097-364-36) / 1 INJECTION in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 15 UNITS BASE/VIAL
Approval Date:	Mar 11, 2019	TE:		RLD:	No

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