Details for New Drug Application (NDA): 064163
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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 |
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 | 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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