DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 077318
NDA 077318 describes CETIRIZINE HYDROCHLORIDE ALLERGY, which is a drug marketed by Apotex Inc, Aurobindo Pharma Ltd, Bionpharma Inc, Strides Pharma, Sun Pharm Inds Inc, Perrigo R And D, Actavis Elizabeth, Amneal Pharms Ny, Cipla Ltd, Contract Pharmacal, Dr Reddys Labs Ltd, Granules India Ltd, Ipca Labs Ltd, Marksans Pharma, Mylan, Orchid Hlthcare, Pld Acquisitions, Sun Pharm Inds Ltd, Taro, Torrent Pharms Llc, Unichem, Unique Pharm Labs, and Wockhardt, and is included in twenty-seven NDAs. It is available from one hundred and thirty 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 sixty 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 sixty suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 077318
| Tradename: | CETIRIZINE HYDROCHLORIDE ALLERGY |
| Applicant: | Cipla Ltd |
| Ingredient: | cetirizine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 077318
Suppliers and Packaging for NDA: 077318
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | TABLET;ORAL | 077318 | ANDA | Wal-Mart Stores, Inc. | 49035-312 | 49035-312-05 | 1 BOTTLE in 1 CARTON (49035-312-05) > 90 TABLET, FILM COATED in 1 BOTTLE |
| CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | TABLET;ORAL | 077318 | ANDA | Wal-Mart Stores, Inc. | 49035-312 | 49035-312-56 | 1 BLISTER PACK in 1 CARTON (49035-312-56) > 14 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Jul 25, 2013 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Jul 25, 2013 | TE: | RLD: | No | |||||
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