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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-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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