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Details for New Drug Application (NDA): 065013

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NDA 065013 describes TOBRAMYCIN SULFATE, which is a drug marketed by Teva Pharms Usa, Mylan Labs Ltd, Hospira, West-ward Pharms Int, X Gen Pharms, Igi Labs Inc, Apothecon, Fresenius Kabi Usa, Watson Labs Inc, Claris, Akorn, and Xellia Pharms Aps, and is included in twenty-seven NDAs. It is available from nine suppliers. Additional details are available on the TOBRAMYCIN SULFATE profile page.

The generic ingredient in TOBRAMYCIN SULFATE is tobramycin sulfate. There are eighteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the tobramycin sulfate profile page.

Summary for NDA: 065013

Tradename:
TOBRAMYCIN SULFATE
Applicant:
X Gen Pharms
Ingredient:
tobramycin sulfate
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 065013

Ingredient-typeAminoglycosides

Suppliers and Packaging for NDA: 065013

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOBRAMYCIN SULFATE
tobramycin sulfate
INJECTABLE;INJECTION 065013 ANDA X-GEN Pharmaceuticals, Inc. 39822-0409 39822-0409-6 6 CARTON in 1 CARTON (39822-0409-6) > 1 VIAL in 1 CARTON (39822-0409-1) > 30 mL in 1 VIAL
TOBRAMYCIN SULFATE
tobramycin sulfate
INJECTABLE;INJECTION 065013 ANDA X-GEN Pharmaceuticals, Inc. 39822-0412 39822-0412-1 1 VIAL in 1 CARTON (39822-0412-1) > 30 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1.2GM BASE/VIAL
Approval Date:Aug 17, 2001TE:APRLD:Yes


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