Details for New Drug Application (NDA): 208964
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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 208964
Tradename: | TOBRAMYCIN |
Applicant: | Lupin |
Ingredient: | tobramycin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 208964
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TOBRAMYCIN | tobramycin | SOLUTION;INHALATION | 208964 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-962 | 68180-962-56 | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | 300MG/5ML | ||||
Approval Date: | Mar 22, 2017 | TE: | AN | RLD: | No |
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