Details for New Drug Application (NDA): 212971
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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 212971
Tradename: | FEXOFENADINE HYDROCHLORIDE |
Applicant: | L Perrigo Co |
Ingredient: | fexofenadine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212971
Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 212971
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FEXOFENADINE HYDROCHLORIDE | fexofenadine hydrochloride | TABLET;ORAL | 212971 | ANDA | L. Perrigo Company | 0113-0847 | 0113-0847-22 | 15 BLISTER PACK in 1 CARTON (0113-0847-22) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
FEXOFENADINE HYDROCHLORIDE | fexofenadine hydrochloride | TABLET;ORAL | 212971 | ANDA | L. Perrigo Company | 0113-0847 | 0113-0847-39 | 1 BOTTLE in 1 CARTON (0113-0847-39) / 30 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
Approval Date: | Feb 24, 2020 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 180MG | ||||
Approval Date: | Feb 24, 2020 | TE: | RLD: | No |
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