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Details for New Drug Application (NDA): 064045

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NDA 064045 describes AMIKACIN SULFATE, which is a drug marketed by Fresenius Kabi Usa, West-ward Pharms Int, Sagent Pharms, Emcure Pharms Ltd, Teva Pharms Usa, Hospira, Abbott, and Igi Labs Inc, and is included in twenty NDAs. It is available from five suppliers. Additional details are available on the AMIKACIN SULFATE profile page.

The generic ingredient in AMIKACIN SULFATE is amikacin sulfate. There are fifteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amikacin sulfate profile page.

Summary for NDA: 064045

Tradename:
AMIKACIN SULFATE
Applicant:
Teva Pharms Usa
Ingredient:
amikacin sulfate
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 064045

Ingredient-typeAminoglycosides

Suppliers and Packaging for NDA: 064045

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMIKACIN SULFATE
amikacin sulfate
INJECTABLE;INJECTION 064045 ANDA Teva Parenteral Medicines, Inc. 0703-9032 0703-9032-93 10 VIAL, SINGLE-DOSE in 1 CARTON (0703-9032-93) > 2 mL in 1 VIAL, SINGLE-DOSE (0703-9032-91)
AMIKACIN SULFATE
amikacin sulfate
INJECTABLE;INJECTION 064045 ANDA Teva Parenteral Medicines, Inc. 0703-9032 0703-9032-03 10 VIAL, SINGLE-DOSE in 1 CARTON (0703-9032-03) > 2 mL in 1 VIAL, SINGLE-DOSE (0703-9032-01)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/ML
Approval Date:Sep 28, 1993TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/ML
Approval Date:Sep 28, 1993TE:APRLD:No


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