Details for New Drug Application (NDA): 219032
NDA 219032 describes FEXOFENADINE HYDROCHLORIDE, which is a drug marketed by Barr, Aurobindo Pharma Ltd, P And L, Contract Pharmacal, Dr Reddys, Dr Reddys Labs Ltd, L Perrigo Co, Rising, Teva, Granules, Hetero Labs Ltd V, Pharmazone, Sciegen Pharms, Sun Pharm Inds, Unique, Aurobindo Pharma, Impax Pharms, and Sun Pharm, and is included in twenty-six NDAs. It is available from thirty-four suppliers. Additional details are available on the FEXOFENADINE HYDROCHLORIDE profile page.
The generic ingredient in FEXOFENADINE HYDROCHLORIDE is fexofenadine hydrochloride; pseudoephedrine hydrochloride. There are two drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride; pseudoephedrine hydrochloride profile page.
The generic ingredient in FEXOFENADINE HYDROCHLORIDE is fexofenadine hydrochloride; pseudoephedrine hydrochloride. There are two drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride; pseudoephedrine hydrochloride profile page.
Summary for 219032
| Tradename: | FEXOFENADINE HYDROCHLORIDE |
| Applicant: | Contract Pharmacal |
| Ingredient: | fexofenadine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 219032
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 219032
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FEXOFENADINE HYDROCHLORIDE | fexofenadine hydrochloride | TABLET;ORAL | 219032 | ANDA | YYBA Corp | 73581-012 | 73581-012-01 | 100 TABLET in 1 BOTTLE (73581-012-01) |
| FEXOFENADINE HYDROCHLORIDE | fexofenadine hydrochloride | TABLET;ORAL | 219032 | ANDA | YYBA Corp | 73581-012 | 73581-012-02 | 200 TABLET in 1 BOTTLE (73581-012-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
| Approval Date: | Feb 28, 2025 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 180MG | ||||
| Approval Date: | Feb 28, 2025 | TE: | RLD: | No | |||||
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