Details for New Drug Application (NDA): 209346
✉ Email this page to a colleague
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 |
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 |
Complete Access Available with Subscription