Details for New Drug Application (NDA): 078357
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NDA 078357 describes DESLORATADINE, which is a drug marketed by Taro, Reddys, Belcher Pharms, Chartwell Rx, Dash Pharms, Dr Reddys Labs Ltd, Lupin Pharms, Orbion Pharms, Perrigo, and Sun Pharm Inds, and is included in twelve NDAs. It is available from seven suppliers. Additional details are available on the DESLORATADINE profile page.
The generic ingredient in DESLORATADINE 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 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 078357
| Tradename: | DESLORATADINE |
| Applicant: | Orbion Pharms |
| Ingredient: | desloratadine |
| Patents: | 0 |
Pharmacology for NDA: 078357
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 078357
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DESLORATADINE | desloratadine | TABLET;ORAL | 078357 | ANDA | Bionpharma Inc. | 69452-363 | 69452-363-20 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-363-20) |
| DESLORATADINE | desloratadine | TABLET;ORAL | 078357 | ANDA | Bionpharma Inc. | 69452-363 | 69452-363-30 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-363-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Feb 19, 2010 | TE: | AB | RLD: | No | ||||
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