Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 8, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065185

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NDA 065185 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 065185
Tradename:BLEOMYCIN SULFATE
Applicant:Fresenius Kabi Usa
Ingredient:bleomycin sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065185
Medical Subject Heading (MeSH) Categories for 065185
Suppliers and Packaging for NDA: 065185
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BLEOMYCIN SULFATE bleomycin sulfate INJECTABLE;INJECTION 065185 ANDA Fresenius Kabi USA, LLC 63323-136 63323-136-10 1 VIAL in 1 CARTON (63323-136-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
BLEOMYCIN SULFATE bleomycin sulfate INJECTABLE;INJECTION 065185 ANDA Fresenius Kabi USA, LLC 63323-137 63323-137-20 1 VIAL in 1 CARTON (63323-137-20) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 15 UNITS BASE/VIAL
Approval Date:Jan 28, 2008TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 30 UNITS BASE/VIAL
Approval Date:Jan 28, 2008TE:APRLD:No

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