Details for New Drug Application (NDA): 063116
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NDA 063116 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 063116
| Tradename: | TOBRAMYCIN SULFATE (PHARMACY BULK) |
| Applicant: | Hospira |
| Ingredient: | tobramycin sulfate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | May 18, 1992 | TE: | RLD: | No | |||||
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