Details for New Drug Application (NDA): 210915
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The generic ingredient in TOBRAMYCIN 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 210915
Tradename: | TOBRAMYCIN |
Applicant: | Teva Pharms Usa |
Ingredient: | tobramycin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 210915
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TOBRAMYCIN | tobramycin | SOLUTION;INHALATION | 210915 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-3750 | 0093-3750-28 | 7 POUCH in 1 CARTON (0093-3750-28) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE |
TOBRAMYCIN | tobramycin | SOLUTION;INHALATION | 210915 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-3750 | 0093-3750-63 | 14 POUCH in 1 CARTON (0093-3750-63) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | 300MG/4ML | ||||
Approval Date: | Jun 26, 2019 | TE: | AN | RLD: | No |
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