Details for New Drug Application (NDA): 213466
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NDA 213466 describes FEXOFENADINE HYDROCHLORIDE, which is a drug marketed by Barr, Aurobindo Pharma Ltd, P And L, Dr Reddys Labs Ltd, L Perrigo Co, Rising, Teva, Granules, Hetero Labs Ltd V, Sciegen Pharms Inc, Sun Pharm Inds, Unique, Wockhardt, Aurobindo Pharma, Dr Reddys, Impax Pharms, and Sun Pharm, and is included in twenty-two NDAs. It is available from forty-three suppliers. Additional details are available on the FEXOFENADINE HYDROCHLORIDE profile page.
The generic ingredient in FEXOFENADINE HYDROCHLORIDE is fexofenadine hydrochloride; pseudoephedrine hydrochloride. There are twenty-three 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 twenty-three 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 213466
| Tradename: | FEXOFENADINE HYDROCHLORIDE |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | fexofenadine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 213466
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 213466
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FEXOFENADINE HYDROCHLORIDE | fexofenadine hydrochloride | SUSPENSION;ORAL | 213466 | ANDA | Aurohealth LLC | 58602-426 | 58602-426-20 | 1 BOTTLE in 1 CARTON (58602-426-20) / 240 mL in 1 BOTTLE |
| FEXOFENADINE HYDROCHLORIDE | fexofenadine hydrochloride | SUSPENSION;ORAL | 213466 | ANDA | Aurohealth LLC | 58602-426 | 58602-426-24 | 1 BOTTLE in 1 CARTON (58602-426-24) / 120 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SUSPENSION;ORAL | Strength | 30MG/5ML | ||||
| Approval Date: | May 23, 2023 | TE: | RLD: | No | |||||
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