Details for New Drug Application (NDA): 209621
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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 209621
Tradename: | TOBRAMYCIN SULFATE |
Applicant: | Gland Pharma Ltd |
Ingredient: | tobramycin sulfate |
Patents: | 0 |
Suppliers and Packaging for NDA: 209621
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 209621 | ANDA | Gland Pharma Limited | 68083-253 | 68083-253-25 | 25 VIAL, MULTI-DOSE in 1 CARTON (68083-253-25) / 2 mL in 1 VIAL, MULTI-DOSE (68083-253-01) |
TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 209621 | ANDA | Gland Pharma Limited | 68083-254 | 68083-254-25 | 25 VIAL, MULTI-DOSE in 1 CARTON (68083-254-25) / 2 mL in 1 VIAL, MULTI-DOSE (68083-254-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10MG BASE/ML | ||||
Approval Date: | Feb 11, 2021 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 40MG BASE/ML | ||||
Approval Date: | Feb 11, 2021 | TE: | AP | RLD: | No |
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