Details for New Drug Application (NDA): 065407
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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 065407
Tradename: | TOBRAMYCIN SULFATE |
Applicant: | Mylan Labs Ltd |
Ingredient: | tobramycin sulfate |
Patents: | 0 |
Suppliers and Packaging for NDA: 065407
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 065407 | ANDA | Mylan Institutional LLC | 67457-428 | 67457-428-30 | 10 VIAL in 1 CARTON (67457-428-30) / 30 mL in 1 VIAL (67457-428-00) |
TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 065407 | ANDA | Mylan Institutional LLC | 67457-473 | 67457-473-22 | 25 VIAL in 1 CARTON (67457-473-22) / 2 mL in 1 VIAL (67457-473-00) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 40MG BASE/ML | ||||
Approval Date: | Mar 11, 2008 | TE: | AP | RLD: | No |
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