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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Citi
Baxter
AstraZeneca
Colorcon
Farmers Insurance
Johnson and Johnson
Deloitte
McKinsey

Generated: June 21, 2018

DrugPatentWatch Database Preview

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. It is available from one supplier. 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. One supplier is listed for this compound. Additional details are available on the acrivastine; pseudoephedrine hydrochloride profile page.
Summary for 019806
Tradename:SEMPREX-D
Applicant:Auxilium Pharms Llc
Ingredient:acrivastine; pseudoephedrine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 019806
Suppliers and Packaging for NDA: 019806
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SEMPREX-D acrivastine; pseudoephedrine hydrochloride CAPSULE;ORAL 019806 NDA Endo Pharmaceuticals, Inc. 52244-404 N 52244-404-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage: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 ➤ Sign Up ➤ Sign Up
Auxilium Pharms Llc SEMPREX-D acrivastine; pseudoephedrine hydrochloride CAPSULE;ORAL 019806-001 Mar 25, 1994 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

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