Details for New Drug Application (NDA): 204226
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NDA 204226 describes CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, which is a drug marketed by Amneal 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, Torrent, Tris Pharma Inc, Jubilant Generics, Novel Labs Inc, Sandoz, and Sun Pharm, and is included in twenty NDAs. It is available from forty-nine 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-seven 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-seven suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 204226
| Tradename: | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY |
| Applicant: | Perrigo R And D |
| Ingredient: | cetirizine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204226
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 204226
Suppliers and Packaging for NDA: 204226
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | SYRUP;ORAL | 204226 | ANDA | L. Perrigo Company | 0113-0189 | 0113-0189-26 | 1 BOTTLE in 1 CARTON (0113-0189-26) / 118 mL in 1 BOTTLE |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | SYRUP;ORAL | 204226 | ANDA | L. Perrigo Company | 0113-0503 | 0113-0503-26 | 1 BOTTLE in 1 CARTON (0113-0503-26) / 118 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SYRUP;ORAL | Strength | 5MG/5ML | ||||
| Approval Date: | Sep 9, 2013 | TE: | RLD: | No | |||||
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