Details for New Drug Application (NDA): 078488
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NDA 078488 describes CETIRIZINE HYDROCHLORIDE, which is a drug marketed by Actavis Mid Atlantic, Amneal Pharms, Apozeal Pharms, Aurobindo Pharma Ltd, Bajaj, Bionpharma, Chartwell Molecular, Lannett Co Inc, Padagis Us, Pharm Assoc, Ranbaxy Labs Ltd, Taro, Teva Pharms, Wockhardt, Indoco, Apotex, 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, Torrent Pharms Llc, Unichem, Unique, Ivax Sub Teva Pharms, and Ppi-dac, and is included in fifty NDAs. It is available from eighteen suppliers. Additional details are available on the CETIRIZINE HYDROCHLORIDE profile page.
The generic ingredient in CETIRIZINE HYDROCHLORIDE is cetirizine hydrochloride; pseudoephedrine hydrochloride. There are thirty-nine drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.
The generic ingredient in CETIRIZINE HYDROCHLORIDE is cetirizine hydrochloride; pseudoephedrine hydrochloride. There are thirty-nine drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.
Summary for 078488
| Tradename: | CETIRIZINE HYDROCHLORIDE |
| Applicant: | Bionpharma |
| Ingredient: | cetirizine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 078488
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 078488
Suppliers and Packaging for NDA: 078488
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE | cetirizine hydrochloride | SOLUTION;ORAL | 078488 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-837 | 51991-837-04 | 120 mL in 1 BOTTLE (51991-837-04) |
| CETIRIZINE HYDROCHLORIDE | cetirizine hydrochloride | SOLUTION;ORAL | 078488 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-837 | 51991-837-16 | 480 mL in 1 BOTTLE (51991-837-16) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 5MG/5ML | ||||
| Approval Date: | Oct 6, 2008 | TE: | AA | RLD: | No | ||||
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