Details for New Drug Application (NDA): 020786
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NDA 020786 describes ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION, which is a drug marketed by Chattem Sanofi and is included in one NDA. It is available from one supplier. Additional details are available on the ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION profile page.
The generic ingredient in ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION is fexofenadine hydrochloride; pseudoephedrine hydrochloride. There are twenty-three drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride; pseudoephedrine hydrochloride profile page.
The generic ingredient in ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION is fexofenadine hydrochloride; pseudoephedrine hydrochloride. There are twenty-three drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride; pseudoephedrine hydrochloride profile page.
Summary for 020786
| Tradename: | ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION |
| Applicant: | Chattem Sanofi |
| Ingredient: | fexofenadine hydrochloride; pseudoephedrine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 020786
| Mechanism of Action | Adrenergic alpha-Agonists Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 020786
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION | fexofenadine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020786 | NDA | Chattem, Inc. | 41167-4310 | 41167-4310-2 | 1 BLISTER PACK in 1 CARTON (41167-4310-2) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
| ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION | fexofenadine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020786 | NDA | Chattem, Inc. | 41167-4310 | 41167-4310-4 | 2 BLISTER PACK in 1 CARTON (41167-4310-4) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 60MG;120MG | ||||
| Approval Date: | Jan 24, 2011 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020786
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Chattem Sanofi | ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION | fexofenadine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020786-002 | Jan 24, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Chattem Sanofi | ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION | fexofenadine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020786-002 | Jan 24, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Chattem Sanofi | ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION | fexofenadine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020786-002 | Jan 24, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Chattem Sanofi | ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION | fexofenadine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020786-002 | Jan 24, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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