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Generated: December 11, 2018

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Details for New Drug Application (NDA): 065111

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NDA 065111 describes KANAMYCIN SULFATE, which is a drug marketed by Abraxis Pharm, Fresenius Kabi Usa, Intl Medication, Loch, Pharmafair, Solopak, Warner Chilcott, and Watson Labs, and is included in twelve NDAs. It is available from one supplier. Additional details are available on the KANAMYCIN SULFATE profile page.

The generic ingredient in KANAMYCIN SULFATE is kanamycin sulfate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the kanamycin sulfate profile page.
Summary for 065111
Applicant:Fresenius Kabi Usa
Ingredient:kanamycin sulfate
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 065111
Suppliers and Packaging for NDA: 065111
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KANAMYCIN SULFATE kanamycin sulfate INJECTABLE;INJECTION 065111 ANDA Fresenius Kabi USA, LLC 63323-359 63323-359-03 10 VIAL in 1 TRAY (63323-359-03) > 3 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/2ML
Approval Date:Dec 17, 2002TE:RLD:No

Profile for product number 002

Approval Date:Dec 17, 2002TE:RLD:No

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