Details for New Drug Application (NDA): 078398
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The generic ingredient in CETIRIZINE HYDROCHLORIDE is cetirizine hydrochloride; pseudoephedrine hydrochloride. There are thirty-nine drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.
Summary for 078398
Tradename: | CETIRIZINE HYDROCHLORIDE |
Applicant: | Padagis Us |
Ingredient: | cetirizine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078398
Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 078398
Suppliers and Packaging for NDA: 078398
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CETIRIZINE HYDROCHLORIDE | cetirizine hydrochloride | SYRUP;ORAL | 078398 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-626 | 45802-626-26 | 1 BOTTLE in 1 CARTON (45802-626-26) / 120 mL in 1 BOTTLE |
CETIRIZINE HYDROCHLORIDE | cetirizine hydrochloride | SYRUP;ORAL | 078398 | ANDA | A-S Medication Solutions | 50090-4288 | 50090-4288-0 | 1 BOTTLE in 1 CARTON (50090-4288-0) / 120 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 5MG/5ML | ||||
Approval Date: | Jun 17, 2008 | TE: | AA | RLD: | No |
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