Product NDC: | 0078-0630 |
Proprietary Name: | TOBI Podhaler |
Non Proprietary Name: | Tobramycin |
Active Ingredient(s): | 28 mg/1 & nbsp; Tobramycin |
Administration Route(s): | ORAL; RESPIRATORY (INHALATION) |
Dosage Form(s): | CAPSULE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0078-0630 |
Labeler Name: | Novartis Pharmaceuticals Corporation |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA201688 |
Marketing Category: | NDA |
Start Marketing Date: | 20130322 |
Package NDC: | 0078-0630-35 |
Package Description: | 224 PACKAGE in 1 BOX, UNIT-DOSE (0078-0630-35) > 56 BLISTER PACK in 1 PACKAGE (0078-0630-56) > 4 CAPSULE in 1 BLISTER PACK (0078-0630-11) |
NDC Code | 0078-0630-35 |
Proprietary Name | TOBI Podhaler |
Package Description | 224 PACKAGE in 1 BOX, UNIT-DOSE (0078-0630-35) > 56 BLISTER PACK in 1 PACKAGE (0078-0630-56) > 4 CAPSULE in 1 BLISTER PACK (0078-0630-11) |
Product NDC | 0078-0630 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Tobramycin |
Dosage Form Name | CAPSULE |
Route Name | ORAL; RESPIRATORY (INHALATION) |
Start Marketing Date | 20130322 |
Marketing Category Name | NDA |
Labeler Name | Novartis Pharmaceuticals Corporation |
Substance Name | TOBRAMYCIN |
Strength Number | 28 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] |