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Generated: January 17, 2019

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Details for New Drug Application (NDA): 050095

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NDA 050095 describes CAPASTAT SULFATE, which is a drug marketed by Akorn and is included in one NDA. It is available from one supplier. Additional details are available on the CAPASTAT SULFATE profile page.

The generic ingredient in CAPASTAT SULFATE is capreomycin sulfate. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the capreomycin sulfate profile page.
Summary for 050095
Ingredient:capreomycin sulfate
Formulation / Manufacturing:see details
Pharmacology for NDA: 050095
Medical Subject Heading (MeSH) Categories for 050095
Suppliers and Packaging for NDA: 050095
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPASTAT SULFATE capreomycin sulfate INJECTABLE;INJECTION 050095 NDA Akorn 17478-080 17478-080-50 1 INJECTION, POWDER, FOR SOLUTION in 1 CARTON (17478-080-50)

Profile for product number 001

Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Argus Health
Chinese Patent Office

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