Product NDC: | 10122-820 |
Proprietary Name: | BETHKIS |
Non Proprietary Name: | tobramycin |
Active Ingredient(s): | 300 mg/4mL & nbsp; tobramycin |
Administration Route(s): | RESPIRATORY (INHALATION) |
Dosage Form(s): | SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 10122-820 |
Labeler Name: | Cornerstone Therapeutics Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA201820 |
Marketing Category: | NDA |
Start Marketing Date: | 20130415 |
Package NDC: | 10122-820-56 |
Package Description: | 14 POUCH in 1 CARTON (10122-820-56) > 4 AMPULE in 1 POUCH > 4 mL in 1 AMPULE (10122-820-04) |
NDC Code | 10122-820-56 |
Proprietary Name | BETHKIS |
Package Description | 14 POUCH in 1 CARTON (10122-820-56) > 4 AMPULE in 1 POUCH > 4 mL in 1 AMPULE (10122-820-04) |
Product NDC | 10122-820 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | tobramycin |
Dosage Form Name | SOLUTION |
Route Name | RESPIRATORY (INHALATION) |
Start Marketing Date | 20130415 |
Marketing Category Name | NDA |
Labeler Name | Cornerstone Therapeutics Inc. |
Substance Name | TOBRAMYCIN |
Strength Number | 300 |
Strength Unit | mg/4mL |
Pharmaceutical Classes | Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] |