Details for New Drug Application (NDA): 021909
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NDA 021909 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 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 | 41167-4232-6 | 4 BLISTER PACK in 1 CARTON (41167-4232-6) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
| CHILDREN'S ALLEGRA HIVES | 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ORALLY DISINTEGRATING;ORAL | Strength | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | 6,037,353 | ⤷ Get Started Free |
| Chattem Sanofi | CHILDREN'S ALLEGRA HIVES | fexofenadine hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021909-003 | Jan 24, 2011 | 7,138,524 | ⤷ Get Started Free |
| Chattem Sanofi | CHILDREN'S ALLEGRA ALLERGY | fexofenadine hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021909-002 | Jan 24, 2011 | 6,399,632 | ⤷ Get Started Free |
| Chattem Sanofi | CHILDREN'S ALLEGRA HIVES | fexofenadine hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021909-003 | Jan 24, 2011 | 5,738,872 | ⤷ Get Started Free |
| Chattem Sanofi | CHILDREN'S ALLEGRA ALLERGY | fexofenadine hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021909-002 | Jan 24, 2011 | 5,578,610 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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