Product Information |
DR-XY45966_PI_01.pdf
|
Registration Number |
DR-XY45966
|
Generic Name |
Ledipasvir + Sofosbuvir
|
Brand Name |
Ledvir
|
Dosage Strength |
90 mg / 400 mg
|
Dosage Form |
Film-Coated Tablet
|
Classification |
Prescription Drug (RX)
|
Pharmacologic Category |
Direct-Acting Antiviral
|
Packaging |
HDPE Bottle x 28's (Box of 28 tablets)
|
Manufacturer |
Mylan Laboratories Limited
|
Country of Origin |
India
|
Trader |
|
Importer |
Viatris Pharmaceuticals, Inc.
|
Distributor |
Viatris Pharmaceuticals, Inc.
|
Application Type |
Initial (from Monitored Release)
|
Issuance Date |
11 July 2024
|
Expiry Date |
17 July 2027
|