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Generated: June 26, 2017

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 NDA: 019806

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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 Actient Pharmaceuticals, LLC 52244-404 52244-404-10 100 CAPSULE in 1 BOTTLE, PLASTIC (52244-404-10)

Summary for product number 001

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

Expired Orange Book 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;ORAL019806-001Mar 25, 19944,501,893► Subscribe
Auxilium Pharms Llc
SEMPREX-D
acrivastine; pseudoephedrine hydrochloride
CAPSULE;ORAL019806-001Mar 25, 19944,650,807► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Baxter
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Cantor Fitzgerald
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Healthtrust
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Dow
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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