| Product Information |
|
| Registration Number |
DRP-11557
|
| Generic Name |
Dextromethorphan Hydrobromide +
Phenylpropanolamine Hydrochloride + Chlorpheniramine
Maleate + Sodium Citrate
|
| Brand Name |
Saphendex
|
| Dosage Strength |
15 mg/10 mg/2 mg/200 mg per 5 mL
|
| Dosage Form |
Syrup (Cherry Flavor)
|
| Classification |
Over-The-Counter (OTC)
|
| Pharmacologic Category |
Antitussive/Nasal Decongestant/Antihistamine/Urinary Alkalizer
|
| Packaging |
PET Round Amber Bottle with White ROPP Aluminum
Cap x 60 mL and 120 mL (Box of 1's)
|
| Manufacturer |
Enicar Pharmaceuticals Pvt. Ltd.
|
| Country of Origin |
India
|
| Trader |
Sapphire Lifesciences Pvt. Ltd.
|
| Importer |
Nelpa Lifesciences, Inc.
|
| Distributor |
Nelpa Lifesciences, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
29 March 2022
|
| Expiry Date |
29 March 2027
|