Details for New Drug Application (NDA): 078692
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NDA 078692 describes CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, which is a drug marketed by Amneal Pharms, Apozeal Pharms, Aurobindo Pharma, Bajaj, Chartwell Molecular, Chartwell Rx, Cypress Pharm, Hetero Labs Ltd Iii, Perrigo R And D, Pharm Assoc, Quagen, Ranbaxy Labs Ltd, Taro, Tris Pharma Inc, Jubilant Generics, Novel Labs Inc, Sandoz, and Sun Pharm, and is included in twenty NDAs. It is available from forty-eight suppliers. Additional details are available on the CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY profile page.
The generic ingredient in CHILDREN'S 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 CHILDREN'S 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 078692
| Tradename: | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY |
| Applicant: | Sandoz |
| Ingredient: | cetirizine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078692
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 078692
Suppliers and Packaging for NDA: 078692
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | TABLET, CHEWABLE;ORAL | 078692 | ANDA | Sandoz Inc | 0781-5283 | 0781-5283-64 | 30 BLISTER PACK in 1 CARTON (0781-5283-64) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (0781-5283-06) |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | TABLET, CHEWABLE;ORAL | 078692 | ANDA | Sandoz Inc | 0781-5284 | 0781-5284-64 | 30 BLISTER PACK in 1 CARTON (0781-5284-64) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (0781-5284-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 5MG | ||||
| Approval Date: | Feb 14, 2008 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 10MG | ||||
| Approval Date: | Feb 14, 2008 | TE: | RLD: | No | |||||
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