Details for New Drug Application (NDA): 206793
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The generic ingredient in CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and fifty-four suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 206793
Tradename: | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY |
Applicant: | Novel Labs Inc |
Ingredient: | cetirizine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 206793
Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 206793
Suppliers and Packaging for NDA: 206793
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | TABLET, CHEWABLE;ORAL | 206793 | ANDA | Novel Laboratories, Inc. | 40032-652 | 40032-652-03 | 1 BOTTLE in 1 CARTON (40032-652-03) / 30 TABLET, CHEWABLE in 1 BOTTLE |
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | TABLET, CHEWABLE;ORAL | 206793 | ANDA | Novel Laboratories, Inc. | 40032-652 | 40032-652-10 | 1000 TABLET, CHEWABLE in 1 BOTTLE (40032-652-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 5MG | ||||
Approval Date: | Mar 8, 2016 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 10MG | ||||
Approval Date: | Mar 8, 2016 | TE: | RLD: | No |
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