Details for New Drug Application (NDA): 022578
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NDA 022578 describes ZYRTEC ALLERGY, which is a drug marketed by Kenvue Brands and is included in two NDAs. It is available from seven suppliers. Additional details are available on the ZYRTEC ALLERGY profile page.
The generic ingredient in ZYRTEC ALLERGY is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and sixty suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
The generic ingredient in ZYRTEC ALLERGY is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and sixty suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 022578
| Tradename: | ZYRTEC ALLERGY |
| Applicant: | Kenvue Brands |
| Ingredient: | cetirizine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 022578
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 022578
Suppliers and Packaging for NDA: 022578
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZYRTEC ALLERGY | cetirizine hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 022578 | NDA | Kenvue Brands LLC | 50580-778 | 50580-778-24 | 4 BLISTER PACK in 1 CARTON (50580-778-24) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
| ZYRTEC ALLERGY | cetirizine hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 022578 | NDA | Kenvue Brands LLC | 50580-782 | 50580-782-01 | 2 CARTON in 1 PACKAGE (50580-782-01) / 4 BLISTER PACK in 1 CARTON / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 10MG | ||||
| Approval Date: | Sep 3, 2010 | TE: | RLD: | Yes | |||||
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