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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 065407


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NDA 065407 describes TOBRAMYCIN SULFATE, which is a drug marketed by Apothecon, Baxter Hlthcare Corp, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Igi Labs Inc, Mylan Labs Ltd, Slate Run Pharma, Teva Pharms Usa, Watson Labs Inc, Xellia Pharms Aps, and Xgen Pharms, and is included in thirty-two NDAs. It is available from eleven 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. Eleven suppliers are listed for this compound. Additional details are available on the tobramycin sulfate profile page.
Summary for 065407
Tradename:TOBRAMYCIN SULFATE
Applicant:Mylan Labs Ltd
Ingredient:tobramycin sulfate
Patents:0
Pharmacology for NDA: 065407
Suppliers and Packaging for NDA: 065407
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 065407 ANDA Mylan Institutional LLC 67457-428 67457-428-30 10 VIAL in 1 CARTON (67457-428-30) / 30 mL in 1 VIAL (67457-428-00)
TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 065407 ANDA Mylan Institutional LLC 67457-473 67457-473-22 25 VIAL in 1 CARTON (67457-473-22) / 2 mL in 1 VIAL (67457-473-00)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 40MG BASE/ML
Approval Date:Mar 11, 2008TE:APRLD:No

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