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Last Updated: April 26, 2024

Details for New Drug Application (NDA): 019806


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NDA 019806 describes SEMPREX-D, which is a drug marketed by Auxilium Pharms Llc and is included in one NDA. Additional details are available on the SEMPREX-D profile page.

The generic ingredient in SEMPREX-D is acrivastine; pseudoephedrine hydrochloride. There are two drug master file entries for this compound. Additional details are available on the acrivastine; pseudoephedrine hydrochloride profile page.
Summary for 019806

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength8MG;60MG
Approval Date:Mar 25, 1994TE:RLD:Yes

Expired US Patents for NDA 019806

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Auxilium Pharms Llc SEMPREX-D acrivastine; pseudoephedrine hydrochloride CAPSULE;ORAL 019806-001 Mar 25, 1994 ⤷  Try a Trial ⤷  Try a Trial
Auxilium Pharms Llc SEMPREX-D acrivastine; pseudoephedrine hydrochloride CAPSULE;ORAL 019806-001 Mar 25, 1994 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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