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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, Solopak, Fresenius Kabi Usa, Watson Labs, Loch, Intl Medication, Pharmafair, and Warner Chilcott, 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 NDA: 065111

Fresenius Kabi Usa
kanamycin sulfate
Therapeutic Class:Antibacterials

Suppliers and Packaging for NDA: 065111

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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

Summary for product number 001

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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/3ML
Approval Date:Dec 17, 2002TE:RLD:Yes

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