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Generated: September 25, 2018

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Details for New Drug Application (NDA): 006460

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NDA 006460 describes PROTAMINE SULFATE, which is a drug marketed by Fresenius Kabi Usa, Lilly, Pharmacia And Upjohn, and West-ward Pharms Int, and is included in five NDAs. It is available from one supplier. Additional details are available on the PROTAMINE SULFATE profile page.

The generic ingredient in PROTAMINE SULFATE is protamine sulfate. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the protamine sulfate profile page.
Summary for 006460
Tradename:PROTAMINE SULFATE
Applicant:Lilly
Ingredient:protamine sulfate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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