Details for New Drug Application (NDA): 214478
✉ Email this page to a colleague
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 214478
Tradename: | TOBRAMYCIN |
Applicant: | Mankind Pharma |
Ingredient: | tobramycin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 214478
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TOBRAMYCIN | tobramycin | SOLUTION;INHALATION | 214478 | ANDA | Lifestar Pharma LLC | 70756-604 | 70756-604-56 | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | 300MG/5ML | ||||
Approval Date: | Jun 30, 2023 | TE: | AN | RLD: | No |
Complete Access Available with Subscription