Product NDC: | 35356-215 |
Proprietary Name: | Spiriva |
Non Proprietary Name: | tiotropium bromide |
Active Ingredient(s): | 18 ug/1 & nbsp; tiotropium bromide |
Administration Route(s): | ORAL; RESPIRATORY (INHALATION) |
Dosage Form(s): | CAPSULE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 35356-215 |
Labeler Name: | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021395 |
Marketing Category: | NDA |
Start Marketing Date: | 20051011 |
Package NDC: | 35356-215-30 |
Package Description: | 3 BLISTER PACK in 1 CARTON (35356-215-30) > 10 CAPSULE in 1 BLISTER PACK |
NDC Code | 35356-215-30 |
Proprietary Name | Spiriva |
Package Description | 3 BLISTER PACK in 1 CARTON (35356-215-30) > 10 CAPSULE in 1 BLISTER PACK |
Product NDC | 35356-215 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | tiotropium bromide |
Dosage Form Name | CAPSULE |
Route Name | ORAL; RESPIRATORY (INHALATION) |
Start Marketing Date | 20051011 |
Marketing Category Name | NDA |
Labeler Name | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC |
Substance Name | TIOTROPIUM BROMIDE MONOHYDRATE |
Strength Number | 18 |
Strength Unit | ug/1 |
Pharmaceutical Classes | Anticholinergic [EPC],Cholinergic Antagonists [MoA] |