Details for New Drug Application (NDA): 204097
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NDA 204097 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-eight 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 three 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 three suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.
Summary for 204097
| Tradename: | FEXOFENADINE HYDROCHLORIDE ALLERGY |
| Applicant: | Hetero Labs Ltd V |
| Ingredient: | fexofenadine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 204097
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 204097
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | fexofenadine hydrochloride | TABLET;ORAL | 204097 | ANDA | NorthStar RxLLC | 16714-899 | 16714-899-01 | 1 BOTTLE in 1 CARTON (16714-899-01) / 30 TABLET in 1 BOTTLE |
| CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | fexofenadine hydrochloride | TABLET;ORAL | 204097 | ANDA | NorthStar RxLLC | 16714-899 | 16714-899-02 | 1 BOTTLE in 1 CARTON (16714-899-02) / 100 TABLET in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
| Approval Date: | Aug 19, 2016 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
| Approval Date: | Aug 19, 2016 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 180MG | ||||
| Approval Date: | Aug 19, 2016 | TE: | RLD: | No | |||||
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