Details for New Drug Application (NDA): 209089
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NDA 209089 describes XYZAL ALLERGY 24HR, which is a drug marketed by Chattem Sanofi and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the XYZAL ALLERGY 24HR profile page.
The generic ingredient in XYZAL ALLERGY 24HR is levocetirizine dihydrochloride. There are thirteen drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.
The generic ingredient in XYZAL ALLERGY 24HR is levocetirizine dihydrochloride. There are thirteen drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.
Summary for 209089
| Tradename: | XYZAL ALLERGY 24HR |
| Applicant: | Chattem Sanofi |
| Ingredient: | levocetirizine dihydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 209089
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 209089
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XYZAL ALLERGY 24HR | levocetirizine dihydrochloride | TABLET;ORAL | 209089 | NDA | Chattem, Inc. | 41167-3510 | 41167-3510-0 | 1 BLISTER PACK in 1 CARTON (41167-3510-0) / 10 TABLET in 1 BLISTER PACK |
| XYZAL ALLERGY 24HR | levocetirizine dihydrochloride | TABLET;ORAL | 209089 | NDA | Chattem, Inc. | 41167-3510 | 41167-3510-1 | 1 BOTTLE in 1 CARTON (41167-3510-1) / 35 TABLET in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Jan 31, 2017 | TE: | RLD: | Yes | |||||
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