FDA.reportPublic FDA data

Application 022327

Type
NDA
Sponsor
PERRIGO PHARMA INTL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREVACID 24 HRLANSOPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL15MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0067-6286PrevacidLansoprazoleGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-6286PrevacidLansoprazoleGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-6286PrevacidLansoprazoleGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-6286PrevacidLansoprazoleGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0113-6002Prevacid 24 HRlansoprazoleL. Perrigo CompanyNDACurrent
0113-6002Prevacid 24 HRlansoprazoleL. Perrigo CompanyNDACurrent
0113-6002Prevacid 24 HRlansoprazoleL. Perrigo CompanyNDACurrent
0113-6002Prevacid 24 HRlansoprazoleL. Perrigo CompanyNDACurrent
0113-6002Prevacid 24 HRlansoprazoleL. Perrigo CompanyNDACurrent
68071-1883PrevacidLansoprazoleNuCare Pharmaceuticals,Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73071SUPPL2023-01-03
73066SUPPL2023-01-03
71457SUPPL2022-06-27
71443SUPPL2022-06-24
70395SUPPL2022-03-03
70353SUPPL2022-03-02
58284SUPPL2019-04-10
58283SUPPL2019-04-10
50589SUPPL2017-12-04
50556SUPPL2017-12-01
47470SUPPL2017-03-06
47431SUPPL2017-03-02
29601SUPPL2015-07-09
38582SUPPL2015-07-02
38581SUPPL2013-11-26
38580SUPPL2013-11-26
38579SUPPL2013-11-26
38578SUPPL2013-11-26
38577SUPPL2013-11-26
17244SUPPL2013-11-26
17243SUPPL2013-11-26
17245SUPPL2013-11-19
29600SUPPL2012-09-24
29599SUPPL2012-04-25
29598SUPPL2012-04-09
44182ORIG2011-12-20
7243SUPPL2011-11-02
7242SUPPL2011-09-29
7241SUPPL2011-04-20
7240SUPPL2010-12-06
7239SUPPL2010-12-06
7238SUPPL2010-09-20
44738ORIG2009-08-03
42493ORIG2009-08-03
29597ORIG2009-05-22