| Product Information |
|
| Registration Number |
DRP-9578
|
| Generic Name |
Sitagliptin Phosphate + Metformin Hydrochloride
|
| Brand Name |
Janumet XR
|
| Dosage Strength |
100mg / 1g
|
| Dosage Form |
Extended Release Film Coated Tablet
|
| Classification |
Prescription Drug (RX)
|
| Packaging |
White HDPE Plastic Bottle x 28's and 30's; White
HDPE Plastic Bottle x 7's (as Physician's Sample)
|
| Pharmacologic Category |
-
|
| Manufacturer |
MSD International GmbH (Puerto Rico Branch) LLC
|
| Country of Origin |
Puerto Rico
|
| Trader |
|
| Importer |
Merck Sharp & Dohme (1.A.) LLC
|
| Distributor |
|
| Application Type |
Initial
|
| Issuance Date |
04 March 2021
|
| Expiry Date |
04 March 2026
|