| Product Information |
|
| Registration Number |
DRP-13757
|
| Generic Name |
Dextromethorphan Hydrobromide
|
| Brand Name |
Saphtorphan-10
|
| Dosage Strength |
10 mg
|
| Dosage Form |
Tablet
|
| Classification |
Over-the-Counter (OTC)
|
| Pharmacologic Category |
-
|
| Packaging |
Alu/Clear PVC Blister Pack x 20's (Box of 100's)
|
| Manufacturer |
Sapphire Lifesciences Pvt. Ltd.
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Nelpa Lifesciences, Inc.
|
| Distributor |
Nelpa Lifesciences, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
19 April 2023
|
| Expiry Date |
19 April 2028
|