| Product Information |
|
| Registration Number |
DRP-12312
|
| Generic Name |
Esomeprazole (as magnesium trihydrate)
|
| Brand Name |
Esomeprasaph-40
|
| Dosage Strength |
40 mg
|
| Dosage Form |
Enteric-Coated Tablet
|
| Classification |
Prescription Drug (RX)
|
| Packaging |
Alu/Alu blister pack x 7's (Box of 14's); Alu/Alu
blister pack x 14's (Box of 14's); Alu/Alu blister pack x 10's (Box 30's)
|
| Pharmacologic Category |
Proton Pump Inhibitor
|
| Manufacturer |
Sapphire Lifesciences Pvt. Ltd.
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
Nelpa Lifesiences, Inc.
|
| Distributor |
Nelpa Lifesiences, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
15 July 2022
|
| Expiry Date |
15 July 2027
|