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Generated: November 18, 2018

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Details for New Drug Application (NDA): 062452

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NDA 062452 describes GENOPTIC, which is a drug marketed by Allergan and is included in one NDA. It is available from seven suppliers. Additional details are available on the GENOPTIC profile page.

The generic ingredient in GENOPTIC 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 062452
Tradename:GENOPTIC
Applicant:Allergan
Ingredient:gentamicin sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 062452
Ingredient-typeAminoglycosides
Suppliers and Packaging for NDA: 062452
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GENOPTIC gentamicin sulfate SOLUTION/DROPS;OPHTHALMIC 062452 ANDA Rebel Distributors Corp 21695-187 21695-187-05 5 mL in 1 BOTTLE, DROPPER (21695-187-05)
GENOPTIC gentamicin sulfate SOLUTION/DROPS;OPHTHALMIC 062452 ANDA Rebel Distributors Corp 21695-187 21695-187-15 15 mL in 1 BOTTLE, DROPPER (21695-187-15)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.3% BASE
Approval Date:Oct 10, 1984TE:ATRLD:No

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