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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 204040


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NDA 204040 describes AMIKACIN SULFATE, which is a drug marketed by Abbott, Avet Lifesciences, Fresenius Kabi Usa, Hikma, Hospira, Igi Labs Inc, Meitheal, and Sagent Pharms Inc, and is included in twenty NDAs. It is available from four 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 204040
Tradename:AMIKACIN SULFATE
Applicant:Avet Lifesciences
Ingredient:amikacin sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204040
Medical Subject Heading (MeSH) Categories for 204040
Suppliers and Packaging for NDA: 204040
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMIKACIN SULFATE amikacin sulfate INJECTABLE;INJECTION 204040 ANDA Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-290 23155-290-41 10 VIAL, GLASS in 1 CARTON (23155-290-41) / 2 mL in 1 VIAL, GLASS (23155-290-31)
AMIKACIN SULFATE amikacin sulfate INJECTABLE;INJECTION 204040 ANDA Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-290 23155-290-42 10 VIAL, GLASS in 1 CARTON (23155-290-42) / 4 mL in 1 VIAL, GLASS (23155-290-32)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/ML
Approval Date:Dec 12, 2013TE:APRLD:No

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