Details for New Drug Application (NDA): 213466
✉ Email this page to a colleague
The generic ingredient in FEXOFENADINE HYDROCHLORIDE is fexofenadine hydrochloride; pseudoephedrine hydrochloride. There are twenty-three drug master file entries for this compound. Twenty-eight 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 |
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 |
Complete Access Available with Subscription