Details for New Drug Application (NDA): 078352
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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 078352
Tradename: | DESLORATADINE |
Applicant: | Lupin Pharms |
Ingredient: | desloratadine |
Patents: | 0 |
Pharmacology for NDA: 078352
Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 078352
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DESLORATADINE | desloratadine | TABLET;ORAL | 078352 | ANDA | A-S Medication Solutions | 50090-4794 | 50090-4794-1 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-4794-1) |
DESLORATADINE | desloratadine | TABLET;ORAL | 078352 | ANDA | A-S Medication Solutions | 50090-6724 | 50090-6724-0 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6724-0) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Oct 25, 2010 | TE: | AB | RLD: | No |
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