Details for New Drug Application (NDA): 218017
✉ Email this page to a colleague
NDA 218017 describes LORATADINE AND PSEUDOEPHEDRINE SULFATE, which is a drug marketed by Bionpharma, Heritage Pharma, P And L, Perrigo Pharma Intl, and Sun Pharm Inds Ltd, and is included in six NDAs. It is available from thirty-one suppliers. Additional details are available on the LORATADINE AND PSEUDOEPHEDRINE SULFATE profile page.
The generic ingredient in LORATADINE AND PSEUDOEPHEDRINE SULFATE is loratadine; pseudoephedrine sulfate. There are thirty-nine drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.
The generic ingredient in LORATADINE AND PSEUDOEPHEDRINE SULFATE is loratadine; pseudoephedrine sulfate. There are thirty-nine drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.
Summary for 218017
| Tradename: | LORATADINE AND PSEUDOEPHEDRINE SULFATE |
| Applicant: | Bionpharma |
| Ingredient: | loratadine; pseudoephedrine sulfate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG;240MG | ||||
| Approval Date: | May 14, 2024 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
