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Covington
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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065031

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NDA 065031 describes BLEOMYCIN SULFATE, which is a drug marketed by Fresenius Kabi Usa, Hong Kong, Hospira, Pharmachemie Bv, Teva Parenteral, Teva Pharms Usa, and West-ward Pharms Int, and is included in seven NDAs. It is available from four 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. Four 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 065031
Medical Subject Heading (MeSH) Categories for 065031
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 N 0409-0323-20
BLEOMYCIN SULFATE bleomycin sulfate INJECTABLE;INJECTION 065031 ANDA Hospira, Inc. 0409-0332 N 0409-0332-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 15 UNITS BASE/VIAL
Approval Date:Mar 10, 2000TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 30 UNITS BASE/VIAL
Approval Date:Mar 10, 2000TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

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