Details for New Drug Application (NDA): 210622
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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 210622
Tradename: | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY |
Applicant: | Hetero Labs Ltd Iii |
Ingredient: | cetirizine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210622
Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 210622
Suppliers and Packaging for NDA: 210622
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | SYRUP;ORAL | 210622 | ANDA | A-S Medication Solutions | 50090-4741 | 50090-4741-0 | 1 BOTTLE in 1 CARTON (50090-4741-0) / 118 mL in 1 BOTTLE |
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | SYRUP;ORAL | 210622 | ANDA | Camber Consumer Care | 69230-316 | 69230-316-11 | 1 BOTTLE in 1 CARTON (69230-316-11) / 118 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | SYRUP;ORAL | Strength | 5MG/5ML | ||||
Approval Date: | Mar 13, 2019 | TE: | RLD: | No |
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