Details for New Drug Application (NDA): 064163
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NDA 064163 describes GENTAK, which is a drug marketed by Pharmobedient and is included in one NDA. It is available from two 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-two 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-two suppliers are listed for this compound. Additional details are available on the gentamicin sulfate profile page.
Summary for 064163
| Tradename: | GENTAK |
| Applicant: | Pharmobedient |
| Ingredient: | gentamicin sulfate |
| Patents: | 0 |
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 | Proficient Rx LP | 63187-764 | 63187-764-05 | 1 BOTTLE, DROPPER in 1 CARTON (63187-764-05) / 5 mL in 1 BOTTLE, DROPPER |
| GENTAK | gentamicin sulfate | SOLUTION/DROPS;OPHTHALMIC | 064163 | ANDA | NuCare Pharmaceuticals, Inc. | 66267-971 | 66267-971-05 | 1 BOTTLE, DROPPER in 1 CARTON (66267-971-05) / 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 12, 2001 | TE: | RLD: | No | |||||
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