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Generated: October 21, 2018

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Details for New Drug Application (NDA): 074567

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NDA 074567 describes IBUPROHM COLD AND SINUS, which is a drug marketed by Ohm Labs and is included in one NDA. It is available from nineteen suppliers. Additional details are available on the IBUPROHM COLD AND SINUS profile page.

The generic ingredient in IBUPROHM COLD AND SINUS 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.
Summary for 074567
Pharmacology for NDA: 074567
Suppliers and Packaging for NDA: 074567
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBUPROHM COLD AND SINUS ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 074567 ANDA WALGREEN COMPANY 0363-0423 0363-0423-21 20 TABLET, COATED in 1 BLISTER PACK (0363-0423-21)
IBUPROHM COLD AND SINUS ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 074567 ANDA WALGREEN COMPANY 0363-0423 0363-0423-41 40 TABLET, COATED in 1 BLISTER PACK (0363-0423-41)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength200MG;30MG
Approval Date:Apr 17, 2001TE:RLD:No

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