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Application 021374

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADVIL COLD AND SINUSIBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDECAPSULE;ORALEQ 200MG FREE ACID AND POTASSIUM SALT;30MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0573-0184ADVIL COLD AND SINUSibuprofen, pseudoephedrine hydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0184ADVIL COLD AND SINUSibuprofen, pseudoephedrine hydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0184ADVIL COLD AND SINUSibuprofen, pseudoephedrine hydrochlorideWyeth Consumer Healthcare LLCNDACurrent
0573-0184ADVIL COLD AND SINUSibuprofen, pseudoephedrine hydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69401SUPPL2021-11-23
69381SUPPL2021-11-23
47816SUPPL2017-04-03
47813SUPPL2017-04-03
27638SUPPL2011-03-16
5223SUPPL2009-05-27
27637SUPPL2008-06-24
27635SUPPL2006-04-20
27636SUPPL2005-12-15
42128ORIG2004-05-26
15340SUPPL2003-10-22
5222SUPPL2003-10-22
36795ORIG2002-05-30
27634ORIG2002-05-30