Details for New Drug Application (NDA): 019835
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NDA 019835 describes ZYRTEC HIVES, which is a drug marketed by Kenvue Brands and is included in one NDA. It is available from seven suppliers. Additional details are available on the ZYRTEC HIVES profile page.
The generic ingredient in ZYRTEC HIVES is cetirizine hydrochloride. There is one drug master file entry for this compound. One hundred and sixty-two suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
The generic ingredient in ZYRTEC HIVES is cetirizine hydrochloride. There is one drug master file entry for this compound. One hundred and sixty-two suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 019835
| Tradename: | ZYRTEC HIVES |
| Applicant: | Kenvue Brands |
| Ingredient: | cetirizine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 019835
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 019835
Suppliers and Packaging for NDA: 019835
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZYRTEC ALLERGY | cetirizine hydrochloride | TABLET;ORAL | 019835 | NDA | Kenvue Brands LLC | 50580-116 | 50580-116-30 | 1 BOTTLE in 1 CARTON (50580-116-30) / 30 TABLET, FILM COATED in 1 BOTTLE |
| ZYRTEC ALLERGY | cetirizine hydrochloride | TABLET;ORAL | 019835 | NDA | Kenvue Brands LLC | 50580-726 | 50580-726-03 | 50 BLISTER PACK in 1 CARTON (50580-726-03) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 003
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Nov 16, 2007 | TE: | RLD: | Yes | |||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Nov 16, 2007 | TE: | RLD: | Yes | |||||
Profile for product number 005
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Nov 16, 2007 | TE: | RLD: | Yes | |||||
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