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Generated: February 20, 2019

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Details for New Drug Application (NDA): 063315

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NDA 063315 describes AMIKACIN SULFATE, which is a drug marketed by Abbott, Emcure Pharms Ltd, Fresenius Kabi Usa, Hospira, Igi Labs Inc, Sagent Pharms, Teva Pharms Usa, and West-ward Pharms Int, 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. Six suppliers are listed for this compound. Additional details are available on the amikacin sulfate profile page.
Summary for 063315
Applicant:West-ward Pharms Int
Ingredient:amikacin sulfate
Formulation / Manufacturing:see details
Pharmacology for NDA: 063315
Medical Subject Heading (MeSH) Categories for 063315
Suppliers and Packaging for NDA: 063315
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMIKACIN SULFATE amikacin sulfate INJECTABLE;INJECTION 063315 ANDA West-Ward Pharmaceuticals Corp. 0641-6166 0641-6166-10 10 VIAL in 1 CARTON (0641-6166-10) > 4 mL in 1 VIAL (0641-6166-01)
AMIKACIN SULFATE amikacin sulfate INJECTABLE;INJECTION 063315 ANDA West-Ward Pharmaceuticals Corp. 0641-6167 0641-6167-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0641-6167-10) > 2 mL in 1 VIAL, SINGLE-DOSE (0641-6167-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/ML
Approval Date:Apr 11, 1994TE:APRLD:No

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