Details for New Drug Application (NDA): 020872
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NDA 020872 describes CHILDREN'S ALLEGRA HIVES, which is a drug marketed by Chattem Sanofi and is included in three NDAs. It is available from four suppliers. There is one patent protecting this drug. Additional details are available on the CHILDREN'S ALLEGRA HIVES profile page.
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.
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 020872
| Tradename: | CHILDREN'S ALLEGRA HIVES |
| Applicant: | Chattem Sanofi |
| Ingredient: | fexofenadine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 020872
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 020872
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALLEGRA ALLERGY | fexofenadine hydrochloride | TABLET;ORAL | 020872 | NDA | Chattem, Inc. | 41167-4120 | 41167-4120-0 | 1 BLISTER PACK in 1 CARTON (41167-4120-0) / 5 TABLET, FILM COATED in 1 BLISTER PACK |
| ALLEGRA ALLERGY | fexofenadine hydrochloride | TABLET;ORAL | 020872 | NDA | Chattem, Inc. | 41167-4120 | 41167-4120-2 | 3 BLISTER PACK in 1 CARTON (41167-4120-2) / 5 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 005
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | |||||
Profile for product number 006
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
| Approval Date: | Jan 24, 2011 | TE: | RLD: | Yes | |||||
Profile for product number 007
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
| Approval Date: | Jan 24, 2011 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020872
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Chattem Sanofi | ALLEGRA HIVES | fexofenadine hydrochloride | TABLET;ORAL | 020872-009 | Jan 24, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Chattem Sanofi | ALLEGRA ALLERGY | fexofenadine hydrochloride | TABLET;ORAL | 020872-007 | Jan 24, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Chattem Sanofi | ALLEGRA HIVES | fexofenadine hydrochloride | TABLET;ORAL | 020872-009 | Jan 24, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Chattem Sanofi | ALLEGRA HIVES | fexofenadine hydrochloride | TABLET;ORAL | 020872-009 | Jan 24, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Chattem Sanofi | CHILDREN'S ALLEGRA HIVES | fexofenadine hydrochloride | TABLET;ORAL | 020872-006 | Jan 24, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Chattem Sanofi | CHILDREN'S ALLEGRA ALLERGY | fexofenadine hydrochloride | TABLET;ORAL | 020872-005 | Jan 24, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Chattem Sanofi | ALLEGRA ALLERGY | fexofenadine hydrochloride | TABLET;ORAL | 020872-010 | Jan 24, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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