Details for New Drug Application (NDA): 021165
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NDA 021165 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 021165
| Tradename: | CLARINEX |
| Applicant: | Organon |
| Ingredient: | desloratadine |
| Patents: | 0 |
Pharmacology for NDA: 021165
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 021165
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLARINEX | desloratadine | TABLET;ORAL | 021165 | NDA | Organon LLC | 78206-119 | 78206-119-01 | 100 TABLET, FILM COATED in 1 BOTTLE (78206-119-01) |
| CLARINEX | desloratadine | TABLET;ORAL | 021165 | NDA | Organon LLC | 78206-188 | 78206-188-01 | 100 TABLET, FILM COATED in 1 BOTTLE (78206-188-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Dec 21, 2001 | TE: | AB | RLD: | Yes | ||||
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