Details for New Drug Application (NDA): 202039
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NDA 202039 describes FEXOFENADINE HYDROCHLORIDE ALLERGY, which is a drug marketed by Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Granules, Hetero Labs Ltd V, Rising, Sciegen Pharms Inc, Sun Pharm Inds, Teva, Unique, and Wockhardt, and is included in ten NDAs. It is available from eighty-six suppliers. Additional details are available on the FEXOFENADINE HYDROCHLORIDE ALLERGY profile page.
The generic ingredient in FEXOFENADINE HYDROCHLORIDE ALLERGY is fexofenadine hydrochloride. There are twenty-three drug master file entries for this compound. One hundred and four 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 are twenty-three drug master file entries for this compound. One hundred and four suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.
Summary for 202039
| Tradename: | FEXOFENADINE HYDROCHLORIDE ALLERGY |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | fexofenadine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 202039
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 202039
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | fexofenadine hydrochloride | TABLET;ORAL | 202039 | ANDA | 7-eleven | 10202-229 | 10202-229-66 | 1 BLISTER PACK in 1 CARTON (10202-229-66) / 10 TABLET, FILM COATED in 1 BLISTER PACK |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | fexofenadine hydrochloride | TABLET;ORAL | 202039 | ANDA | 7-eleven | 10202-229 | 10202-229-66 | 1 BLISTER PACK in 1 CARTON (10202-229-66) / 10 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
| Approval Date: | Nov 19, 2014 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
| Approval Date: | Nov 19, 2014 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 180MG | ||||
| Approval Date: | Nov 19, 2014 | TE: | RLD: | No | |||||
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