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Generated: November 18, 2018

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Details for New Drug Application (NDA): 062535

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NDA 062535 describes TOBREX, which is a drug marketed by Novartis Pharms Corp and Sandoz Inc and is included in three NDAs. It is available from nine 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 062535
Applicant:Sandoz Inc
Formulation / Manufacturing:see details
Pharmacology for NDA: 062535
Medical Subject Heading (MeSH) Categories for 062535
Suppliers and Packaging for NDA: 062535
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOBREX tobramycin SOLUTION/DROPS;OPHTHALMIC 062535 ANDA Medsource Pharmaceuticals 45865-427 45865-427-01 5 mL in 1 BOTTLE, PLASTIC (45865-427-01)
TOBREX tobramycin SOLUTION/DROPS;OPHTHALMIC 062535 ANDA A-S Medication Solutions 50090-3569 50090-3569-0 5 mL in 1 BOTTLE, PLASTIC (50090-3569-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.3%
Approval Date:Dec 13, 1984TE:ATRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
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