DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 077829
NDA 077829 describes CETIRIZINE HYDROCHLORIDE HIVES, which is a drug marketed by Dr Reddys Labs Ltd, Ipca Labs Ltd, Marksans Pharma, Mylan, Orchid Hlthcare, Perrigo R And D, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Unichem, Unique Pharm Labs, Aurobindo Pharma Ltd, Bionpharma Inc, Amneal Pharms Ny, Taro, and Torrent Pharms Llc, and is included in seventeen NDAs. It is available from eighty-three suppliers. Additional details are available on the CETIRIZINE HYDROCHLORIDE HIVES profile page.
The generic ingredient in CETIRIZINE HYDROCHLORIDE HIVES is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and sixty-one suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
The generic ingredient in CETIRIZINE HYDROCHLORIDE HIVES is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and sixty-one 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 | Kaiser Foundation Hospitals | 0179-8301 | 0179-8301-01 | 100 TABLET in 1 BOTTLE (0179-8301-01) |
| CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | TABLET;ORAL | 077829 | ANDA | Kaiser Foundation Hospitals | 0179-8302 | 0179-8302-01 | 100 TABLET in 1 BOTTLE (0179-8302-01) |
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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