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Generated: September 25, 2018

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Details for New Drug Application (NDA): 077628

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NDA 077628 describes IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Perrigo, Contract Pharmacal, and Dr Reddys Labs Ltd, and is included in four 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. Twenty-two suppliers are listed for this compound. Additional details are available on the ibuprofen; pseudoephedrine hydrochloride profile page.

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength200MG;30MG
Approval Date:Aug 14, 2006TE:RLD:No

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