Details for New Drug Application (NDA): 021605
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NDA 021605 describes CLARINEX D 24 HOUR, which is a drug marketed by Organon and is included in one NDA. Additional details are available on the CLARINEX D 24 HOUR profile page.
The generic ingredient in CLARINEX D 24 HOUR 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 D 24 HOUR 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 021605
| Tradename: | CLARINEX D 24 HOUR |
| Applicant: | Organon |
| Ingredient: | desloratadine; pseudoephedrine sulfate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Mar 3, 2005 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 021605
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Organon | CLARINEX D 24 HOUR | desloratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 021605-001 | Mar 3, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Organon | CLARINEX D 24 HOUR | desloratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 021605-001 | Mar 3, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Organon | CLARINEX D 24 HOUR | desloratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 021605-001 | Mar 3, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Organon | CLARINEX D 24 HOUR | desloratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 021605-001 | Mar 3, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Organon | CLARINEX D 24 HOUR | desloratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 021605-001 | Mar 3, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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