Details for New Drug Application (NDA): 210507
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NDA 210507 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-four 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 is one drug master file entry for this compound. Twenty-five 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 is one drug master file entry for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.
Summary for 210507
| Tradename: | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE |
| Applicant: | Unichem |
| Ingredient: | cetirizine hydrochloride; pseudoephedrine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 210507
| Mechanism of Action | Adrenergic alpha-Agonists Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 210507
| 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 | 210507 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-313 | 29300-313-22 | 2 BLISTER PACK in 1 CARTON (29300-313-22) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (29300-313-61) |
| CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | cetirizine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210507 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-313 | 29300-313-24 | 4 BLISTER PACK in 1 CARTON (29300-313-24) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (29300-313-61) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG;120MG | ||||
| Approval Date: | Sep 10, 2024 | TE: | RLD: | No | |||||
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