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Details for New Drug Application (NDA): 050789
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NDA 050789 describes TOBRAMYCIN SULFATE, which is a drug marketed by Akorn, Apothecon, Baxter Hlthcare Corp, Fresenius Kabi Usa, Hospira, Igi Labs Inc, Mylan Labs Ltd, Teva Pharms Usa, Watson Labs Inc, West-ward Pharms Int, X Gen Pharms, and Xellia Pharms Aps, and is included in twenty-seven NDAs. It is available from seven suppliers. Additional details are available on the TOBRAMYCIN SULFATE profile page.
The generic ingredient in TOBRAMYCIN SULFATE is tobramycin sulfate. There are eighteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the tobramycin sulfate profile page.
The generic ingredient in TOBRAMYCIN SULFATE is tobramycin sulfate. There are eighteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the tobramycin sulfate profile page.
Summary for 050789
| Tradename: | TOBRAMYCIN SULFATE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | tobramycin sulfate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 050789
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 050789 | NDA | Fresenius Kabi USA, LLC | 63323-303 | 63323-303-55 | 6 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-303-55) > 30 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 050789 | NDA | Fresenius Kabi USA, LLC | 63323-303 | 63323-303-51 | 6 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-303-51) > 30 mL in 1 VIAL, PHARMACY BULK PACKAGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1.2GM BASE/VIAL | ||||
| Approval Date: | Jul 13, 2004 | TE: | AP | RLD: | No | ||||
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