| Product Information |
DR-XY46053_PI_01.pdf
|
| Registration Number |
DR-XY46053
|
| Generic Name |
Daclatasvir (as hydrochloride)
|
| Brand Name |
Mydekla 60
|
| Dosage Strength |
60 mg
|
| Dosage Form |
Film Coated Tablet
|
| Classification |
Prescription (Rx) Drug
|
| Pharmacologic Category |
-
|
| Packaging |
HDPE Bottle x 28's (Box of 1's x 28 tablets)
|
| Manufacturer |
Mylan Laboratories Limited
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Viatris Pharmaceuticals, Inc.
|
| Distributor |
Viatris Pharmaceuticals, Inc.
|
| Application Type |
Initial (from Monitored Release)
|
| Issuance Date |
20 December 2023
|
| Expiry Date |
03 October 2027
|