Details for New Drug Application (NDA): 209346
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NDA 209346 describes TOBRAMYCIN SULFATE (PHARMACY BULK), which is a drug marketed by Fresenius Kabi Usa, Gland Pharma Ltd, and Hospira, and is included in three NDAs. It is available from two suppliers. Additional details are available on the TOBRAMYCIN SULFATE (PHARMACY BULK) profile page.
The generic ingredient in TOBRAMYCIN SULFATE (PHARMACY BULK) 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.
The generic ingredient in TOBRAMYCIN SULFATE (PHARMACY BULK) 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 209346
| Tradename: | TOBRAMYCIN SULFATE (PHARMACY BULK) |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | tobramycin sulfate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 209346
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TOBRAMYCIN SULFATE (PHARMACY BULK) | tobramycin sulfate | INJECTABLE;INJECTION | 209346 | ANDA | Gland Pharma Limited | 68083-241 | 68083-241-01 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68083-241-01) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 40MG BASE/ML | ||||
| Approval Date: | Feb 9, 2021 | TE: | AP | RLD: | No | ||||
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