Details for New Drug Application (NDA): 091589
✉ 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 091589
Tradename: | TOBRAMYCIN |
Applicant: | Teva Pharms Usa |
Ingredient: | tobramycin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 091589
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TOBRAMYCIN | tobramycin | SOLUTION;INHALATION | 091589 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-4085 | 0093-4085-63 | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | 300MG/5ML | ||||
Approval Date: | Oct 10, 2013 | TE: | AN | RLD: | No |
Complete Access Available with Subscription