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 six 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-seven suppliers are listed for this compound. Additional details are available on the gentamicin sulfate profile page.
The generic ingredient in GENOPTIC is gentamicin sulfate. There are fifteen drug master file entries for this compound. Twenty-seven 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 |
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 | RPK Pharmaceuticals, Inc. | 53002-9292 | 53002-9292-1 | 5 mL in 1 BOTTLE, DROPPER (53002-9292-1) |
| 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 |
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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