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Serving 500+ biopharmaceutical companies globally:

Accenture
Merck
McKesson
Cantor Fitzgerald
Farmers Insurance
Moodys
Fish and Richardson
Baxter
Medtronic
Johnson and Johnson

Generated: July 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076478

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NDA 076478 describes IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, which is a drug marketed by Dr Reddys Labs Ltd, Perrigo, and Contract Pharmacal, and is included in three NDAs. It is available from one supplier. Additional details are available on the IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE profile page.

The generic ingredient in IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE is ibuprofen; pseudoephedrine hydrochloride. There are sixty-four drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the ibuprofen; pseudoephedrine hydrochloride profile page.

Summary for NDA: 076478

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 076478

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
ibuprofen; pseudoephedrine hydrochloride
SUSPENSION;ORAL 076478 ANDA Amerisource Bergen 24385-549 24385-549-26 1 BOTTLE in 1 CARTON (24385-549-26) > 120 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SUSPENSION;ORALStrength100MG/5ML;15MG/5ML
Approval Date:Nov 5, 2003TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Cerilliant
Moodys
Colorcon
AstraZeneca
Mallinckrodt
Julphar
Baxter
Queensland Health
Chubb
QuintilesIMS

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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