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Details for New Drug Application (NDA): 077829
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The generic ingredient in CETIRIZINE HYDROCHLORIDE HIVES is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and thirty suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 077829
Tradename: | CETIRIZINE HYDROCHLORIDE HIVES |
Applicant: | Unique Pharm Labs |
Ingredient: | cetirizine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077829
Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 077829
Suppliers and Packaging for NDA: 077829
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | TABLET;ORAL | 077829 | ANDA | Rising Pharmaceuticals, Inc. | 16571-401 | 16571-401-10 | 100 TABLET in 1 BOTTLE (16571-401-10) |
CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | TABLET;ORAL | 077829 | ANDA | Rising Pharmaceuticals, Inc. | 16571-402 | 16571-402-10 | 100 TABLET in 1 BOTTLE (16571-402-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Aug 26, 2009 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Aug 26, 2009 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Aug 26, 2009 | TE: | RLD: | No |
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