Details for New Drug Application (NDA): 217519
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The generic ingredient in TOBRAMYCIN SULFATE is tobramycin sulfate. There are eighteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the tobramycin sulfate profile page.
Summary for 217519
Tradename: | TOBRAMYCIN SULFATE |
Applicant: | Eugia Pharma |
Ingredient: | tobramycin sulfate |
Patents: | 0 |
Suppliers and Packaging for NDA: 217519
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 217519 | ANDA | Eugia US LLC | 55150-470 | 55150-470-06 | 6 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-470-06) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE (55150-470-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1.2GM BASE/VIAL | ||||
Approval Date: | Jun 21, 2023 | TE: | AP | RLD: | No |
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