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Generated: June 18, 2019

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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, Hong Kong, Hospira, Pharmachemie Bv, Teva Parenteral, Teva Pharms Usa, and West-ward Pharms Int, and is included in eight NDAs. It is available from seven 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. Seven suppliers are listed for this compound. Additional details are available on the bleomycin sulfate profile page.
Summary for 209439
Ingredient:bleomycin sulfate
Formulation / Manufacturing:see details
Pharmacology for NDA: 209439
Medical Subject Heading (MeSH) Categories for 209439
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

Approval Date:Mar 11, 2019TE:APRLD:No

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