Details for New Drug Application (NDA): 062452
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The generic ingredient in GENOPTIC is gentamicin sulfate. There are fifteen drug master file entries for this compound. Twenty-six 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 |
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 | A-S Medication Solutions | 50090-2333 | 50090-2333-0 | 1 BOTTLE, DROPPER in 1 CARTON (50090-2333-0) / 5 mL in 1 BOTTLE, DROPPER |
GENOPTIC | gentamicin sulfate | SOLUTION/DROPS;OPHTHALMIC | 062452 | ANDA | RPK Pharmaceuticals, Inc. | 53002-9292 | 53002-9292-1 | 5 mL in 1 BOTTLE, DROPPER (53002-9292-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.3% BASE | ||||
Approval Date: | Oct 10, 1984 | TE: | RLD: | No |
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