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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 Alcon and Alcon Labs Inc and is included in three NDAs. It is available from six 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-eight suppliers are listed for this compound. Additional details are available on the tobramycin profile page.

Summary for NDA: 050541

Tradename:
TOBREX
Applicant:
Alcon Labs Inc
Ingredient:
tobramycin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 050541

Ingredient-typeAminoglycosides

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 0065-0643-05 1 BOTTLE, PLASTIC in 1 CARTON (0065-0643-05) > 5 mL in 1 BOTTLE, PLASTIC

Summary 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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