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Details for New Drug Application (NDA): 206965

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NDA 206965 describes TOBRAMYCIN SULFATE, which is a drug marketed by Teva Pharms Usa, Mylan Labs Ltd, Hospira, Eurohlth Intl Sarl, 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: 206965

tobramycin sulfate

Pharmacology for NDA: 206965


Suppliers and Packaging for NDA: 206965

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
tobramycin sulfate
INJECTABLE;INJECTION 206965 ANDA Claris Lifesciences Inc. 36000-242 36000-242-01 1 VIAL in 1 CARTON (36000-242-01) > 30 mL in 1 VIAL
tobramycin sulfate
INJECTABLE;INJECTION 206965 ANDA Claris Lifesciences Inc. 36000-242 36000-242-05 5 VIAL in 1 CARTON (36000-242-05) > 30 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 40MG BASE/ML
Approval Date:Jul 1, 2016TE:APRLD:No

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