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Johnson and Johnson
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Federal Trade Commission
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Moodys
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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050555

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NDA 050555 describes TOBREX, which is a drug marketed by Novartis Pharms Corp and Sandoz Inc and is included in three NDAs. It is available from four suppliers. Additional details are available on the TOBREX profile page.

The generic ingredient in TOBREX is tobramycin. There are eighteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the tobramycin profile page.
Summary for 050555
Tradename:TOBREX
Applicant:Novartis Pharms Corp
Ingredient:tobramycin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 050555
Ingredient-typeAminoglycosides
Medical Subject Heading (MeSH) Categories for 050555
Suppliers and Packaging for NDA: 050555
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOBREX tobramycin OINTMENT;OPHTHALMIC 050555 NDA Alcon Laboratories, Inc. 0065-0644 N 0065-0644-35

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;OPHTHALMICStrength0.3%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Cerilliant
Chubb
Colorcon
Fuji
AstraZeneca
Queensland Health
Deloitte
Express Scripts

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