Product Information |
DR-XY43795_PI_01.pdf
|
Registration Number |
DR-XY43795 (For DOH National Tuberculosis Control Program Use Only)
|
Generic Name |
Bedaquiline (as fumarate)
|
Brand Name |
Sirturo
|
Dosage Strength |
100 mg
|
Dosage Form |
Tablet
|
Classification |
Prescription Drug (Rx)
|
Packaging |
White HDPE plastic bottle x 188's (Box of 1's)
|
Pharmacologic Category |
-
|
Manufacturer |
Recipharm Pharmaservices Private Limited
|
Country of Origin |
India
|
Trader |
N/A
|
Importer |
Johnson & Johnson (Phlippines), Inc.
|
Distributor |
Johnson & Johnson (Phlippines), Inc.
|
Application Type |
Initial (from Monitored Release status) (Correction)
|
Issuance Date |
10 August 2023
|
Expiry Date |
13 October 2024
|