Details for New Drug Application (NDA): 078366
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NDA 078366 describes DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR, which is a drug marketed by Dr Reddys Labs Ltd and is included in one NDA. Additional details are available on the DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR profile page.
The generic ingredient in DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 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 DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 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 078366
| Tradename: | DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR |
| Applicant: | Dr Reddys Labs Ltd |
| Ingredient: | desloratadine; pseudoephedrine sulfate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG;240MG | ||||
| Approval Date: | Apr 26, 2011 | TE: | RLD: | No | |||||
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