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Generated: November 17, 2018

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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 nine 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. Twenty-nine suppliers are listed for this compound. Additional details are available on the gentamicin sulfate profile page.
Summary for 064163
Tradename:GENTAK
Applicant:Akorn
Ingredient:gentamicin sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 064163
Ingredient-typeAminoglycosides
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

Profile 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 hundreds of leading biopharmaceutical companies globally:

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