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Serving leading biopharmaceutical companies globally:

McKinsey
Chinese Patent Office
Baxter
US Department of Justice
Dow
Fish and Richardson
Cipla
Harvard Business School
QuintilesIMS
US Army

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 064052

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NDA 064052 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 sixteen 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 064052
Tradename:TOBRAMYCIN
Applicant:Bausch And Lomb
Ingredient:tobramycin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 064052
Ingredient-typeAminoglycosides
Medical Subject Heading (MeSH) Categories for 064052
Suppliers and Packaging for NDA: 064052
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOBRAMYCIN tobramycin SOLUTION/DROPS;OPHTHALMIC 064052 ANDA MWI 13985-743 13985-743-05 1 BOTTLE, DROPPER in 1 CARTON (13985-743-05) > 5 mL in 1 BOTTLE, DROPPER
TOBRAMYCIN tobramycin SOLUTION/DROPS;OPHTHALMIC 064052 ANDA Bausch & Lomb Incorporated 24208-290 24208-290-05 1 BOTTLE, DROPPER in 1 CARTON (24208-290-05) > 5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.3%
Approval Date:Nov 29, 1993TE:ATRLD:No

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Serving leading biopharmaceutical companies globally:

Colorcon
Novartis
McKesson
Argus Health
Chinese Patent Office
Express Scripts
QuintilesIMS
AstraZeneca
Deloitte

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