Details for New Drug Application (NDA): 204097
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The generic ingredient in FEXOFENADINE HYDROCHLORIDE ALLERGY is fexofenadine hydrochloride. There are twenty-three drug master file entries for this compound. One hundred and two 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 |
Formulation / Manufacturing: | see details |
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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