Details for New Drug Application (NDA): 078780
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NDA 078780 describes CETIRIZINE HYDROCHLORIDE HIVES RELIEF, which is a drug marketed by Aurobindo Pharma Ltd, Bionpharma, Sun Pharm Inds Inc, Amneal Pharms Ny, Taro, and Torrent Pharms Llc, and is included in seven NDAs. It is available from twenty-eight suppliers. Additional details are available on the CETIRIZINE HYDROCHLORIDE HIVES RELIEF profile page.
The generic ingredient in CETIRIZINE HYDROCHLORIDE HIVES RELIEF 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 HIVES RELIEF 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 078780
| Tradename: | CETIRIZINE HYDROCHLORIDE HIVES RELIEF |
| Applicant: | Amneal Pharms Ny |
| Ingredient: | cetirizine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078780
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 078780
Suppliers and Packaging for NDA: 078780
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | TABLET;ORAL | 078780 | ANDA | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-129 | 55910-129-45 | 1 BOTTLE, PLASTIC in 1 BOX (55910-129-45) / 45 TABLET in 1 BOTTLE, PLASTIC |
| CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | TABLET;ORAL | 078780 | ANDA | P & L Development, LLC | 59726-129 | 59726-129-03 | 1 BOTTLE, PLASTIC in 1 BOX (59726-129-03) / 300 TABLET in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Jan 21, 2010 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Jan 21, 2010 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Jan 21, 2010 | TE: | RLD: | No | |||||
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