Details for New Drug Application (NDA): 210137
NDA 210137 describes FEXOFENADINE HYDROCHLORIDE ALLERGY, which is a drug marketed by Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Granules, Hetero Labs Ltd V, Pharmazone, Rising, Sciegen Pharms, Sun Pharm Inds, Teva, and Unique, and is included in ten NDAs. It is available from eighty-seven suppliers. Additional details are available on the FEXOFENADINE HYDROCHLORIDE ALLERGY profile page.
The generic ingredient in FEXOFENADINE HYDROCHLORIDE ALLERGY is fexofenadine hydrochloride. There is one drug master file entry for this compound. One hundred and five suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.
The generic ingredient in FEXOFENADINE HYDROCHLORIDE ALLERGY is fexofenadine hydrochloride. There is one drug master file entry for this compound. One hundred and five suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.
Summary for 210137
| Tradename: | FEXOFENADINE HYDROCHLORIDE ALLERGY |
| Applicant: | Unique |
| Ingredient: | fexofenadine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 210137
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 210137
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FEXOFENADINE HYDROCHLORIDE ALLERGY | fexofenadine hydrochloride | TABLET;ORAL | 210137 | ANDA | CVS Pharmacy | 51316-183 | 51316-183-00 | 180 TABLET in 1 BOTTLE (51316-183-00) |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | fexofenadine hydrochloride | TABLET;ORAL | 210137 | ANDA | Strategic Sourcing Services, LLC | 70677-1239 | 70677-1239-1 | 100 TABLET, FILM COATED in 1 BOTTLE (70677-1239-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 180MG | ||||
| Approval Date: | Aug 13, 2018 | TE: | RLD: | No | |||||
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