Details for New Drug Application (NDA): 021909
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The generic ingredient in CHILDREN'S ALLEGRA HIVES 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 021909
Tradename: | CHILDREN'S ALLEGRA HIVES |
Applicant: | Chattem Sanofi |
Ingredient: | fexofenadine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 021909
Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 021909
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CHILDREN'S ALLEGRA ALLERGY | fexofenadine hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021909 | NDA | Chattem, Inc. | 41167-4232 | 41167-4232-1 | 2 BLISTER PACK in 1 CARTON (41167-4232-1) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
CHILDREN'S ALLEGRA ALLERGY | fexofenadine hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021909 | NDA | Chattem, Inc. | 41167-4232 | 41167-4232-6 | 4 BLISTER PACK in 1 CARTON (41167-4232-6) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 30MG | ||||
Approval Date: | Jan 24, 2011 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Jan 24, 2011 | TE: | RLD: | Yes |
Expired US Patents for NDA 021909
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Chattem Sanofi | CHILDREN'S ALLEGRA HIVES | fexofenadine hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021909-003 | Jan 24, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Chattem Sanofi | CHILDREN'S ALLEGRA HIVES | fexofenadine hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021909-003 | Jan 24, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Chattem Sanofi | CHILDREN'S ALLEGRA ALLERGY | fexofenadine hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021909-002 | Jan 24, 2011 | ⤷ Sign Up | ⤷ Sign Up |
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