Details for New Drug Application (NDA): 090750
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The generic ingredient in CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 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 090750
Tradename: | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF |
Applicant: | Aurobindo Pharma |
Ingredient: | cetirizine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090750
Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 090750
Suppliers and Packaging for NDA: 090750
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | SOLUTION;ORAL | 090750 | ANDA | Fred's, Inc. | 55315-354 | 55315-354-31 | 1 BOTTLE in 1 CARTON (55315-354-31) / 120 mL in 1 BOTTLE |
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | SOLUTION;ORAL | 090750 | ANDA | Aurohealth LLC | 58602-028 | 58602-028-20 | 1 BOTTLE in 1 CARTON (58602-028-20) / 240 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION;ORAL | Strength | 5MG/5ML | ||||
Approval Date: | Feb 2, 2010 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION;ORAL | Strength | 5MG/5ML | ||||
Approval Date: | Feb 2, 2010 | TE: | RLD: | No |
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