Details for New Drug Application (NDA): 021621
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The generic ingredient in CHILDREN'S ZYRTEC HIVES RELIEF 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 021621
Tradename: | CHILDREN'S ZYRTEC HIVES RELIEF |
Applicant: | J And J Consumer Inc |
Ingredient: | cetirizine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 021621
Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 021621
Suppliers and Packaging for NDA: 021621
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CHILDREN'S ZYRTEC ALLERGY | cetirizine hydrochloride | TABLET, CHEWABLE;ORAL | 021621 | NDA | A-S Medication Solutions | 50090-6781 | 50090-6781-0 | 4 BLISTER PACK in 1 CARTON (50090-6781-0) / 6 TABLET, CHEWABLE in 1 BLISTER PACK |
CHILDREN'S ZYRTEC ALLERGY | cetirizine hydrochloride | TABLET, CHEWABLE;ORAL | 021621 | NDA | A-S Medication Solutions | 50090-6845 | 50090-6845-0 | 4 BLISTER PACK in 1 CARTON (50090-6845-0) / 6 TABLET, CHEWABLE in 1 BLISTER PACK |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Nov 16, 2007 | TE: | RLD: | Yes |
Profile for product number 004
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Nov 16, 2007 | TE: | RLD: | Yes |
Profile for product number 005
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Nov 16, 2007 | TE: | RLD: | Yes |
Expired US Patents for NDA 021621
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
J And J Consumer Inc | CHILDREN'S ZYRTEC ALLERGY | cetirizine hydrochloride | TABLET, CHEWABLE;ORAL | 021621-003 | Nov 16, 2007 | ⤷ Sign Up | ⤷ Sign Up |
J And J Consumer Inc | CHILDREN'S ZYRTEC HIVES RELIEF | cetirizine hydrochloride | TABLET, CHEWABLE;ORAL | 021621-006 | Nov 16, 2007 | ⤷ Sign Up | ⤷ Sign Up |
J And J Consumer Inc | CHILDREN'S ZYRTEC HIVES RELIEF | cetirizine hydrochloride | TABLET, CHEWABLE;ORAL | 021621-005 | Nov 16, 2007 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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