Details for New Drug Application (NDA): 209116
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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-eight suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride; pseudoephedrine hydrochloride profile page.
Summary for 209116
Tradename: | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE |
Applicant: | Aurobindo Pharma |
Ingredient: | fexofenadine hydrochloride; pseudoephedrine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 209116
Mechanism of Action | Adrenergic alpha-Agonists Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 209116
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 | 209116 | ANDA | WALGREEN CO. | 0363-0094 | 0363-0094-67 | 2 BLISTER PACK in 1 CARTON (0363-0094-67) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | fexofenadine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209116 | ANDA | WALGREEN CO. | 0363-0094 | 0363-0094-84 | 3 BLISTER PACK in 1 CARTON (0363-0094-84) / 10 TABLET, FILM COATED, 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: | Oct 30, 2017 | TE: | RLD: | No |
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