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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 twenty-nine 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-three drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the ibuprofen; pseudoephedrine hydrochloride profile page.

Summary for NDA: 074567

Tradename:
IBUPROHM COLD AND SINUS
Applicant:
Ohm Labs
Ingredient:
ibuprofen; pseudoephedrine hydrochloride
Patents:0
Formulation / Manufacturing:see details

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 L Perrigo Company 0113-0083 0113-0083-60 2 BLISTER PACK in 1 CARTON (0113-0083-60) > 10 TABLET, SUGAR COATED in 1 BLISTER PACK
IBUPROHM COLD AND SINUS
ibuprofen; pseudoephedrine hydrochloride
TABLET;ORAL 074567 ANDA Walgreen Company 0363-0083 0363-0083-60 2 BLISTER PACK in 1 CARTON (0363-0083-60) > 10 TABLET, SUGAR COATED in 1 BLISTER PACK

Summary for product number 001

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


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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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