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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 063176

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NDA 063176 describes TOBRAMYCIN, which is a drug marketed by Alcon Pharms Ltd, Apotex Inc, Bausch And Lomb, Fera Pharms, Somerset Theraps Llc, Akorn Inc, Amneal Pharms, Lupin Atlantis, Mylan Pharms Inc, Teva Pharms Usa, Akorn, Apothecon, Baxter Hlthcare Corp, Fresenius Kabi Usa, Hospira, Igi Labs Inc, Mylan Labs Ltd, Watson Labs Inc, West-ward Pharms Int, X Gen Pharms, and Xellia Pharms Aps, and is included in thirty-eight NDAs. It is available from fifteen suppliers. Additional details are available on the TOBRAMYCIN profile page.

The generic ingredient in TOBRAMYCIN 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 063176

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 063176

Ingredient-typeAminoglycosides

Suppliers and Packaging for NDA: 063176

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOBRAMYCIN tobramycin SOLUTION/DROPS;OPHTHALMIC 063176 ANDA Rebel Distributors Corp 21695-204 21695-204-05 5 mL in 1 BOTTLE, PLASTIC (21695-204-05)
TOBRAMYCIN tobramycin SOLUTION/DROPS;OPHTHALMIC 063176 ANDA Lake Erie Medical DBA Quaity Care Products LLC 49999-148 49999-148-05 5 mL in 1 BOTTLE, PLASTIC (49999-148-05)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION/DROPS;OPHTHALMICStrength0.3%
Approval Date:May 25, 1994TE:RLD:No


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Serving leading biopharmaceutical companies globally:

Citi
US Army
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Cantor Fitzgerald
Daiichi Sankyo
Colorcon
Baxter
Argus Health
Queensland Health
Express Scripts

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