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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Fish and Richardson
US Army

Generated: March 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 062307

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NDA 062307 describes GENTAMICIN SULFATE, which is a drug marketed by Alpharma Us Pharms, Fougera Pharms Inc, G And W Labs Inc, Perrigo New York, Pharmaderm, Taro, Abbott, Fresenius Kabi Usa, Hospira, Kalapharm, Pharm Spec, Solopak, Teva Parenteral, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Akorn, Perrigo Co Tennessee, Alcon Pharms Ltd, Bausch And Lomb, Paco, Sandoz Inc, B Braun, and Baxter Hlthcare, and is included in thirty-seven NDAs. It is available from twenty suppliers. Additional details are available on the GENTAMICIN SULFATE profile page.

The generic ingredient in GENTAMICIN SULFATE is gentamicin sulfate. There are fifteen drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the gentamicin sulfate profile page.
Summary for 062307
Applicant:Perrigo New York
Ingredient:gentamicin sulfate
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 062307
Suppliers and Packaging for NDA: 062307
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GENTAMICIN SULFATE gentamicin sulfate CREAM;TOPICAL 062307 ANDA Perrigo New York Inc 45802-056 N 45802-056-11
GENTAMICIN SULFATE gentamicin sulfate CREAM;TOPICAL 062307 ANDA Perrigo New York Inc 45802-056 N 45802-056-35

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrengthEQ 0.1% BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Chinese Patent Office
US Department of Justice
Johnson and Johnson

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