| Product Information |
|
| Registration Number |
DRP-11009
|
| Generic Name |
Tiotropium (as bromide)
|
| Brand Name |
Tropair
|
| Dosage Strength |
18 mcg (equivalent to 10 mcg delivered-dose)
|
| Dosage Form |
Dry Powder for Inhalation in Capsule
|
| Classification |
Prescription (Rx) Drug
|
| Pharmacologic Category |
Anticholinergic
|
| Packaging |
PP round plastic container with HDPE cap x 30's (Box of 1's) + RS01 Monodose Inhaler Device (ABS Elix/Lustran M203FC)
|
| Manufacturer |
Mepro Pharmaceuticals Private Limited
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
S.M.H.P. Marketing Consultancy
|
| Distributor |
S.M.H.P. Marketing Consultancy
|
| Application Type |
Initial (Correction)
|
| Issuance Date |
29 May 2024
|
| Expiry Date |
29 December 2026
|