Details for New Drug Application (NDA): 021704
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NDA 021704 describes ALLEGRA-D 24 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 24 HOUR ALLERGY AND CONGESTION profile page.
The generic ingredient in ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION is fexofenadine hydrochloride; pseudoephedrine hydrochloride. There are twenty-three drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride; pseudoephedrine hydrochloride profile page.
The generic ingredient in ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION is fexofenadine hydrochloride; pseudoephedrine hydrochloride. There are twenty-three drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride; pseudoephedrine hydrochloride profile page.
Summary for 021704
| Tradename: | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION |
| Applicant: | Chattem Sanofi |
| Ingredient: | fexofenadine hydrochloride; pseudoephedrine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 021704
| Mechanism of Action | Adrenergic alpha-Agonists Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 021704
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | fexofenadine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021704 | NDA | Chattem, Inc. | 41167-4320 | 41167-4320-5 | 2 BLISTER PACK in 1 CARTON (41167-4320-5) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
| ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | fexofenadine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021704 | NDA | Chattem, Inc. | 41167-4320 | 41167-4320-7 | 3 BLISTER PACK in 1 CARTON (41167-4320-7) / 5 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 | 180MG;240MG | ||||
| Approval Date: | Jan 24, 2011 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 021704
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Chattem Sanofi | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | fexofenadine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021704-002 | Jan 24, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Chattem Sanofi | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | fexofenadine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021704-002 | Jan 24, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Chattem Sanofi | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | fexofenadine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021704-002 | Jan 24, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Chattem Sanofi | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | fexofenadine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021704-002 | Jan 24, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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