Details for New Drug Application (NDA): 078412
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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 078412
Tradename: | CETIRIZINE HYDROCHLORIDE |
Applicant: | Pharm Assoc |
Ingredient: | cetirizine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078412
Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 078412
Suppliers and Packaging for NDA: 078412
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CETIRIZINE HYDROCHLORIDE | cetirizine hydrochloride | SYRUP;ORAL | 078412 | ANDA | PAI Holdings, LLC dba PAI Pharma | 0121-0874 | 0121-0874-16 | 480 mL in 1 BOTTLE (0121-0874-16) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 5MG/5ML | ||||
Approval Date: | Jun 18, 2008 | TE: | AA | RLD: | No |
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