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Generated: March 23, 2018

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Details for New Drug Application (NDA): 050541

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NDA 050541 describes TOBREX, which is a drug marketed by Novartis Pharms Corp and Sandoz Inc and is included in three NDAs. It is available from five 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-four suppliers are listed for this compound. Additional details are available on the tobramycin profile page.
Summary for 050541
Applicant:Novartis Pharms Corp
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 050541
Medical Subject Heading (MeSH) Categories for 050541
Suppliers and Packaging for NDA: 050541
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOBREX tobramycin SOLUTION/DROPS;OPHTHALMIC 050541 NDA Alcon Laboratories, Inc. 0065-0643 N 0065-0643-05

Profile for product number 001

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

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