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Details for New Drug Application (NDA): 064163
NDA 064163 describes GENTAK, which is a drug marketed by Akorn and is included in one NDA. It is available from eight 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-six 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-six 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 |
| Therapeutic Class: | Antibacterials |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 064163
| Ingredient-type | Aminoglycosides |
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 | N | 13985-603-03 |
| GENTAK | gentamicin sulfate | SOLUTION/DROPS;OPHTHALMIC | 064163 | ANDA | Akorn, Inc. | 17478-283 | N | 17478-283-10 |
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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