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, Jubilant Cadista, Mylan, Orchid Hlthcare, Perrigo R And D, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Unichem, Unique Pharm Labs, Bionpharma Inc, Amneal Pharms Ny, Aurobindo Pharma Ltd, Taro, and Torrent Pharms Llc, and is included in sixteen NDAs. It is available from seventy-four 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 forty-two 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 forty-two 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 |
| Therapeutic Class: | Respiratory Tract Agents |
| Formulation / Manufacturing: | see details |
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 | N | 16571-401-10 |
| CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | TABLET;ORAL | 077829 | ANDA | Rising Pharmaceuticals, Inc. | 16571-402 | N | 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 | |||||
Complete Access Available with Subscription
