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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 four 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 NDA: 064163

Tradename:
GENTAK
Applicant:
Akorn
Ingredient:
gentamicin sulfate
Patents:0
Therapeutic Class:Antibacterials
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

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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