Details for New Drug Application (NDA): 212848
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The generic ingredient in TOBRAMYCIN is tobramycin sulfate. There are eighteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the tobramycin sulfate profile page.
Summary for 212848
Tradename: | TOBRAMYCIN |
Applicant: | Alkem Labs Ltd |
Ingredient: | tobramycin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 212848
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TOBRAMYCIN | tobramycin | SOLUTION;INHALATION | 212848 | ANDA | Ascend Laboratories, LLC | 67877-678 | 67877-678-70 | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | 300MG/5ML | ||||
Approval Date: | Apr 1, 2021 | TE: | AN | RLD: | No |
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