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
|