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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 seven 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. Twenty-four suppliers are listed for this compound. Additional details are available on the gentamicin sulfate profile page.
The generic ingredient in GENTAK 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 064163
| Tradename: | GENTAK |
| Applicant: | Akorn |
| Ingredient: | gentamicin sulfate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
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 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.3% BASE | ||||
| Approval Date: | Oct 12, 2001 | TE: | AT | RLD: | No | ||||
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