Details for New Drug Application (NDA): 201373
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NDA 201373 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 three 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 three suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.
Summary for 201373
| Tradename: | CHILDREN'S ALLEGRA HIVES |
| Applicant: | Chattem Sanofi |
| Ingredient: | fexofenadine hydrochloride |
| Patents: | 1 |
Pharmacology for NDA: 201373
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 201373
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHILDREN'S ALLEGRA ALLERGY | fexofenadine hydrochloride | SUSPENSION;ORAL | 201373 | NDA | Chattem, Inc. | 41167-4244 | 41167-4244-1 | 1 BOTTLE in 1 CARTON (41167-4244-1) / 240 mL in 1 BOTTLE |
| CHILDREN'S ALLEGRA ALLERGY | fexofenadine hydrochloride | SUSPENSION;ORAL | 201373 | NDA | Chattem, Inc. | 41167-4244 | 41167-4244-4 | 1 BOTTLE in 1 CARTON (41167-4244-4) / 120 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SUSPENSION;ORAL | Strength | 30MG/5ML | ||||
| Approval Date: | Jan 24, 2011 | TE: | RLD: | Yes | |||||
| Patent: | 8,933,097 | Patent Expiration: | Aug 2, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SUSPENSION;ORAL | Strength | 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jan 24, 2011 | TE: | RLD: | Yes | |||||
| Patent: | 8,933,097 | Patent Expiration: | Aug 2, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 201373
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Chattem Sanofi | CHILDREN'S ALLEGRA HIVES | fexofenadine hydrochloride | SUSPENSION;ORAL | 201373-002 | Jan 24, 2011 | 7,138,524*PED | ⤷ Subscribe |
| Chattem Sanofi | CHILDREN'S ALLEGRA ALLERGY | fexofenadine hydrochloride | SUSPENSION;ORAL | 201373-001 | Jan 24, 2011 | 7,138,524*PED | ⤷ Subscribe |
| Chattem Sanofi | CHILDREN'S ALLEGRA HIVES | fexofenadine hydrochloride | SUSPENSION;ORAL | 201373-002 | Jan 24, 2011 | 6,399,632*PED | ⤷ Subscribe |
| Chattem Sanofi | CHILDREN'S ALLEGRA ALLERGY | fexofenadine hydrochloride | SUSPENSION;ORAL | 201373-001 | Jan 24, 2011 | 5,578,610*PED | ⤷ Subscribe |
| Chattem Sanofi | CHILDREN'S ALLEGRA HIVES | fexofenadine hydrochloride | SUSPENSION;ORAL | 201373-002 | Jan 24, 2011 | 6,037,353*PED | ⤷ Subscribe |
| Chattem Sanofi | CHILDREN'S ALLEGRA HIVES | fexofenadine hydrochloride | SUSPENSION;ORAL | 201373-002 | Jan 24, 2011 | 5,578,610*PED | ⤷ Subscribe |
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