Details for New Drug Application (NDA): 212971
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NDA 212971 describes FEXOFENADINE HYDROCHLORIDE, which is a drug marketed by Barr, Aurobindo Pharma Ltd, P And L, Contract Pharmacal, 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-five NDAs. It is available from thirty-seven 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 212971
| Tradename: | FEXOFENADINE HYDROCHLORIDE |
| Applicant: | L Perrigo Co |
| Ingredient: | fexofenadine hydrochloride |
| Patents: | 0 |
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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