Details for New Drug Application (NDA): 021300
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NDA 021300 describes CLARINEX, which is a drug marketed by Organon Llc and Organon and is included in five NDAs. It is available from one supplier. Additional details are available on the CLARINEX profile page.
The generic ingredient in CLARINEX is desloratadine; pseudoephedrine sulfate. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the desloratadine; pseudoephedrine sulfate profile page.
The generic ingredient in CLARINEX is desloratadine; pseudoephedrine sulfate. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the desloratadine; pseudoephedrine sulfate profile page.
Summary for 021300
| Tradename: | CLARINEX |
| Applicant: | Organon Llc |
| Ingredient: | desloratadine |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Sep 1, 2004 | TE: | RLD: | Yes | |||||
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