Details for New Drug Application (NDA): 022155
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NDA 022155 describes CHILDREN'S ZYRTEC HIVES, which is a drug marketed by Kenvue Brands and is included in two NDAs. It is available from one supplier. Additional details are available on the CHILDREN'S ZYRTEC HIVES profile page.
The generic ingredient in CHILDREN'S ZYRTEC HIVES is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and fifty-eight suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
The generic ingredient in CHILDREN'S ZYRTEC HIVES is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and fifty-eight suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 022155
| Tradename: | CHILDREN'S ZYRTEC HIVES |
| Applicant: | Kenvue Brands |
| Ingredient: | cetirizine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 022155
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 022155
Suppliers and Packaging for NDA: 022155
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHILDREN'S ZYRTEC ALLERGY | cetirizine hydrochloride | SOLUTION;ORAL | 022155 | NDA | Kenvue Brands LLC | 50580-128 | 50580-128-04 | 1 BOTTLE in 1 CARTON (50580-128-04) / 118 mL in 1 BOTTLE |
| CHILDREN'S ZYRTEC ALLERGY | cetirizine hydrochloride | SOLUTION;ORAL | 022155 | NDA | Kenvue Brands LLC | 50580-721 | 50580-721-05 | 1 BOTTLE, PLASTIC in 1 CARTON (50580-721-05) / 118 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION;ORAL | Strength | 5MG/5ML | ||||
| Approval Date: | Nov 16, 2007 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION;ORAL | Strength | 5MG/5ML | ||||
| Approval Date: | Nov 16, 2007 | TE: | RLD: | Yes | |||||
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