Details for New Drug Application (NDA): 078317
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NDA 078317 describes CETIRIZINE HYDROCHLORIDE ALLERGY, which is a drug marketed by Apotex, Aurobindo Pharma Ltd, Bionpharma, Catalent, Strides Pharma, Sun Pharm Inds Inc, Perrigo R And D, Amneal Pharms Ny, Apotex Inc, Cipla Ltd, Contract Pharmacal, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Granules, Heritage Pharma, Ipca Labs Ltd, Marksans Pharma, Mylan, Orbion Pharms, Pld Acquisitions, Sun Pharm Inds Ltd, Taro, Torrent Pharms Llc, Unichem, and Unique, and is included in twenty-eight NDAs. It is available from one hundred and thirty-two suppliers. Additional details are available on the CETIRIZINE HYDROCHLORIDE ALLERGY profile page.
The generic ingredient in CETIRIZINE HYDROCHLORIDE ALLERGY is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and fifty-five suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
The generic ingredient in CETIRIZINE HYDROCHLORIDE ALLERGY is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and fifty-five suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 078317
| Tradename: | CETIRIZINE HYDROCHLORIDE ALLERGY |
| Applicant: | Apotex Inc |
| Ingredient: | cetirizine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078317
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 078317
Suppliers and Packaging for NDA: 078317
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | TABLET;ORAL | 078317 | ANDA | Proficient Rx LP | 63187-932 | 63187-932-15 | 15 TABLET, FILM COATED in 1 BOTTLE (63187-932-15) |
| CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | TABLET;ORAL | 078317 | ANDA | Proficient Rx LP | 63187-932 | 63187-932-30 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-932-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Dec 27, 2007 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Dec 27, 2007 | TE: | RLD: | No | |||||
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