Spiriva - tiotropium bromide monohydrate
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Field |
Value |
NDC Code: |
54868-5109 |
Proprietary Name: |
Spiriva |
Suffix: |
|
Non-Proprietary Name: |
tiotropium bromide monohydrate |
Dosage Form: |
CAPSULE |
Method: |
ORAL; RESPIRATORY (INHALATION) |
Original Marketing Date: |
14-07-2004 |
Category Name: |
NDA |
Application Number: |
NDA021395 |
Labeler: |
PHYSICIANS TOTAL CARE, INC. |
Substance Name: |
TIOTROPIUM BROMIDE MONOHYDRATE |
Active Numerator Strength: |
18 |
Active Ingredient Unit: |
ug/1 |
Pharm Classes: |
Anticholinergic [EPC],Cholinergic Antagonists [MoA] |
DEA Schedule: |
|