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Generated: March 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 064096

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NDA 064096 describes AKTOB, which is a drug marketed by Akorn and is included in one NDA. It is available from eight suppliers. Additional details are available on the AKTOB profile page.

The generic ingredient in AKTOB is tobramycin. There are eighteen drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the tobramycin profile page.
Summary for 064096
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 064096
Medical Subject Heading (MeSH) Categories for 064096
Suppliers and Packaging for NDA: 064096
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AKTOB tobramycin SOLUTION/DROPS;OPHTHALMIC 064096 ANDA Henry Schein Inc. 0404-7196 N 0404-7196-01
AKTOB tobramycin SOLUTION/DROPS;OPHTHALMIC 064096 ANDA Blenheim Pharmacal, Inc. 10544-883 E 10544-883-99

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.3%
Approval Date:Jan 31, 1996TE:ATRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

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