Details for New Drug Application (NDA): 204226
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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-eight suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 204226
Tradename: | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY |
Applicant: | Perrigo R And D |
Ingredient: | cetirizine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 204226
Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 204226
Suppliers and Packaging for NDA: 204226
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | SOLUTION;ORAL | 204226 | ANDA | L. Perrigo Company | 0113-0189 | 0113-0189-26 | 1 BOTTLE in 1 CARTON (0113-0189-26) / 118 mL in 1 BOTTLE |
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | SOLUTION;ORAL | 204226 | ANDA | L. Perrigo Company | 0113-0503 | 0113-0503-26 | 1 BOTTLE in 1 CARTON (0113-0503-26) / 118 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION;ORAL | Strength | 5MG/5ML | ||||
Approval Date: | Sep 9, 2013 | TE: | RLD: | No |
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