Details for New Drug Application (NDA): 078862
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NDA 078862 describes CETIRIZINE HYDROCHLORIDE HIVES, which is a drug marketed by Dr Reddys Labs Ltd, Ipca Labs Ltd, Marksans Pharma, Mylan, Orbion Pharms, Perrigo R And D, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Unichem, Unique, Aurobindo Pharma Ltd, Bionpharma, Amneal Pharms Ny, Taro, and Torrent Pharms Llc, and is included in seventeen 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 fifty-eight 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 fifty-eight suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 078862
| Tradename: | CETIRIZINE HYDROCHLORIDE HIVES |
| Applicant: | Orbion Pharms |
| Ingredient: | cetirizine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 078862
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 078862
Suppliers and Packaging for NDA: 078862
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | TABLET;ORAL | 078862 | ANDA | Bionpharma Inc. | 69452-465 | 69452-465-81 | 400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-465-81) |
| CETIRIZINE HYDROCHLORIDE HIVES | cetirizine hydrochloride | TABLET;ORAL | 078862 | ANDA | Bionpharma Inc. | 69452-465 | 69452-465-81 | 400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-465-81) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Feb 19, 2009 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Feb 19, 2009 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Feb 19, 2009 | TE: | RLD: | No | |||||
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