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Generated: April 20, 2019

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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 ten 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. Thirty suppliers are listed for this compound. Additional details are available on the tobramycin profile page.
Summary for 050555
Applicant:Novartis Pharms Corp
Formulation / Manufacturing:see details
Pharmacology for NDA: 050555
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 0065-0644-35 3.5 g in 1 TUBE (0065-0644-35)
TOBREX tobramycin OINTMENT;OPHTHALMIC 050555 NDA Rebel Distributors Corp 21695-458 21695-458-35 3.5 g in 1 TUBE (21695-458-35)

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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