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Serving leading biopharmaceutical companies globally:

Dow
Federal Trade Commission
Fuji
Chinese Patent Office
Express Scripts
Accenture
Deloitte
Julphar
QuintilesIMS
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Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091071

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NDA 091071 describes GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE, which is a drug marketed by Actavis Labs Fl and is included in one NDA. It is available from sixteen suppliers. Additional details are available on the GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE profile page.

The generic ingredient in GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE is guaifenesin; pseudoephedrine hydrochloride. There are twenty drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the guaifenesin; pseudoephedrine hydrochloride profile page.
Summary for 091071
Suppliers and Packaging for NDA: 091071
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 091071 ANDA L. Perrigo Company 0113-0144 0113-0144-89 18 BLISTER PACK in 1 CARTON (0113-0144-89) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 091071 ANDA L. Perrigo Company 0113-2002 0113-2002-89 18 BLISTER PACK in 1 CARTON (0113-2002-89) > 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength600MG;60MG
Approval Date:May 27, 2015TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength1.2GM;120MG
Approval Date:May 27, 2015TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Accenture
Cerilliant
Fuji
AstraZeneca
Deloitte
McKesson
Baxter
Farmers Insurance

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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