Details for New Drug Application (NDA): 212266
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NDA 212266 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 212266
| Tradename: | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY |
| Applicant: | Quagen |
| Ingredient: | cetirizine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212266
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 212266
Suppliers and Packaging for NDA: 212266
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | SOLUTION;ORAL | 212266 | ANDA | QUAGEN PHARMACEUTICALS LLC | 70752-103 | 70752-103-06 | 1 BOTTLE, PLASTIC in 1 CARTON (70752-103-06) / 118 mL in 1 BOTTLE, PLASTIC |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | SOLUTION;ORAL | 212266 | ANDA | QUAGEN PHARMACEUTICALS LLC | 70752-104 | 70752-104-06 | 1 BOTTLE, PLASTIC in 1 CARTON (70752-104-06) / 118 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION;ORAL | Strength | 5MG/5ML | ||||
| Approval Date: | May 16, 2019 | TE: | RLD: | No | |||||
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