Details for New Drug Application (NDA): 090818
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The generic ingredient in FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 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 090818
Tradename: | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE |
Applicant: | Sun Pharm |
Ingredient: | fexofenadine hydrochloride; pseudoephedrine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 090818
Mechanism of Action | Adrenergic alpha-Agonists Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 090818
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | fexofenadine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 090818 | ANDA | H E B | 37808-999 | 37808-999-30 | 1 BLISTER PACK in 1 CARTON (37808-999-30) / 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | fexofenadine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 090818 | ANDA | PUBLIX SUPER MARKETS, INC | 41415-995 | 41415-995-20 | 1 BLISTER PACK in 1 CARTON (41415-995-20) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 60MG;120MG | ||||
Approval Date: | Jan 29, 2015 | TE: | RLD: | No |
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