Details for New Drug Application (NDA): 212409
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NDA 212409 describes CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Ivax Sub Teva Pharms, Pld Acquisitions, Ppi-dac, Sun Pharm Inds Ltd, and Unichem, and is included in six NDAs. It is available from twenty-five suppliers. Additional details are available on the CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE profile page.
The generic ingredient in CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE is cetirizine hydrochloride; pseudoephedrine hydrochloride. There are thirty-nine drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.
The generic ingredient in CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE is cetirizine hydrochloride; pseudoephedrine hydrochloride. There are thirty-nine drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.
Summary for 212409
| Tradename: | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | cetirizine hydrochloride; pseudoephedrine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 212409
| Mechanism of Action | Adrenergic alpha-Agonists Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 212409
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | cetirizine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212409 | ANDA | Aurohealth LLC | 58602-703 | 58602-703-09 | 12 BLISTER PACK in 1 CARTON (58602-703-09) / 2 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
| CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | cetirizine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212409 | ANDA | Aurohealth LLC | 58602-703 | 58602-703-53 | 12 BLISTER PACK in 1 CARTON (58602-703-53) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG;120MG | ||||
| Approval Date: | Mar 8, 2023 | TE: | RLD: | No | |||||
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