Details for New Drug Application (NDA): 090765
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NDA 090765 describes CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, which is a drug marketed by Amneal Pharms, Apozeal Pharms, Aurobindo Pharma, Bajaj, Chartwell Molecular, Chartwell Rx, Cypress Pharm, Perrigo R And D, Pharm Assoc, Ranbaxy Labs Ltd, Taro, Tris Pharma Inc, Jubilant Generics, and Sun Pharm, and is included in fifteen NDAs. It is available from twenty-six suppliers. Additional details are available on the CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF profile page.
The generic ingredient in CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and fifty-six suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
The generic ingredient in CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and fifty-six suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 090765
| Tradename: | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF |
| Applicant: | Amneal Pharms |
| Ingredient: | cetirizine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 090765
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 090765
Suppliers and Packaging for NDA: 090765
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | SOLUTION;ORAL | 090765 | ANDA | Amneal Pharmaceuticals LLC | 65162-003 | 65162-003-86 | 1 BOTTLE in 1 CARTON (65162-003-86) / 118 mL in 1 BOTTLE |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | SOLUTION;ORAL | 090765 | ANDA | Amneal Pharmaceuticals LLC | 65162-005 | 65162-005-86 | 1 BOTTLE in 1 CARTON (65162-005-86) / 118 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION;ORAL | Strength | 5MG/5ML | ||||
| Approval Date: | Oct 7, 2009 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION;ORAL | Strength | 5MG/5ML | ||||
| Approval Date: | Oct 7, 2009 | TE: | RLD: | No | |||||
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