Details for New Drug Application (NDA): 216792
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NDA 216792 describes FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, Barr, Dr Reddys, Dr Reddys Labs Ltd, Impax Pharms, L Perrigo Co, and Sun Pharm, and is included in nine NDAs. It is available from twenty-seven suppliers. Additional details are available on the FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE profile page.
The generic ingredient in FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE is fexofenadine hydrochloride; pseudoephedrine hydrochloride. There are twenty-three drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride; pseudoephedrine hydrochloride profile page.
The generic ingredient in FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE is fexofenadine hydrochloride; pseudoephedrine hydrochloride. There are twenty-three drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride; pseudoephedrine hydrochloride profile page.
Summary for 216792
| Tradename: | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE |
| Applicant: | L Perrigo Co |
| Ingredient: | fexofenadine hydrochloride; pseudoephedrine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 216792
| Mechanism of Action | Adrenergic alpha-Agonists Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 216792
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | fexofenadine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 216792 | ANDA | Strategic Sourcing Services LLC | 70677-1315 | 70677-1315-1 | 20 BLISTER PACK in 1 CARTON (70677-1315-1) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
| FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | fexofenadine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 216792 | ANDA | Strategic Sourcing Services LLC | 70677-1315 | 70677-1315-2 | 30 BLISTER PACK in 1 CARTON (70677-1315-2) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 60MG;120MG | ||||
| Approval Date: | Oct 7, 2025 | TE: | RLD: | No | |||||
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