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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Chinese Patent Office
Federal Trade Commission
Fish and Richardson
US Army

Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 064163

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NDA 064163 describes GENTAK, which is a drug marketed by Akorn and is included in one NDA. It is available from seven suppliers. Additional details are available on the GENTAK profile page.

The generic ingredient in GENTAK 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 064163

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 064163


Suppliers and Packaging for NDA: 064163

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GENTAK gentamicin sulfate SOLUTION/DROPS;OPHTHALMIC 064163 ANDA MWI 13985-603 13985-603-03 1 TUBE in 1 CARTON (13985-603-03) > 3.5 g in 1 TUBE
GENTAK gentamicin sulfate SOLUTION/DROPS;OPHTHALMIC 064163 ANDA Akorn, Inc. 17478-283 17478-283-10 1 BOTTLE, DROPPER in 1 CARTON (17478-283-10) > 5 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.3% BASE
Approval Date:Oct 12, 2001TE:ATRLD:No

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Daiichi Sankyo
Cantor Fitzgerald

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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