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Express Scripts
Johnson and Johnson

Last Updated: July 7, 2020

DrugPatentWatch Database Preview

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 four 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-four suppliers are listed for this compound. Additional details are available on the gentamicin sulfate profile page.
Summary for 062452
Ingredient:gentamicin sulfate
Formulation / Manufacturing:see details
Pharmacology for NDA: 062452
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 Pacific Pharma, Inc. 60758-188 60758-188-05 1 BOTTLE, DROPPER in 1 CARTON (60758-188-05) > 5 mL in 1 BOTTLE, DROPPER
GENOPTIC gentamicin sulfate SOLUTION/DROPS;OPHTHALMIC 062452 ANDA DIRECT RX 61919-106 61919-106-05 5 mL in 1 CARTON (61919-106-05)

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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Serving leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts

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