Details for New Drug Application (NDA): 207136
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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 207136
Tradename: | TOBRAMYCIN |
Applicant: | Sun Pharm |
Ingredient: | tobramycin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 207136
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TOBRAMYCIN | tobramycin | SOLUTION;INHALATION | 207136 | ANDA | Sun Pharmaceutical Industries, Inc. | 47335-171 | 47335-171-49 | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | 300MG/5ML | ||||
Approval Date: | Dec 26, 2019 | TE: | AN | RLD: | No |
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