FDA.report

Application 207193

Type
ANDA
Sponsor
PERRIGO R AND D

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMCAPSULE, DELAYED RELEASE;ORALEQ 20MG BASENoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-0651good sense esomeprazole magnesiumesomeprazoleL. Perrigo CompanyANDACurrent
0113-0732basic care esomeprazole magnesiumEsomeprazoleL. Perrigo CompanyANDACurrent
0113-0732basic care esomeprazole magnesiumEsomeprazoleL. Perrigo CompanyANDACurrent
0113-0732basic care esomeprazole magnesiumEsomeprazoleL. Perrigo CompanyANDACurrent
0113-0898Good Sense Esomeprazole MagnesiumEsomeprazoleL. Perrigo CompanyANDACurrent
0113-0898Good Sense Esomeprazole MagnesiumEsomeprazoleL. Perrigo CompanyANDACurrent
0113-0898Good Sense Esomeprazole MagnesiumEsomeprazoleL. Perrigo CompanyANDACurrent
0363-1699Esomeprazole MagnesiumesomeprazoleWalgreen CompanyANDACurrent
0363-1699Esomeprazole MagnesiumesomeprazoleWalgreen CompanyANDACurrent
0363-1699Esomeprazole MagnesiumesomeprazoleWalgreen CompanyANDACurrent
0363-1898esomeprazole magnesiumEsomeprazoleWalgreen CompanyANDACurrent
0363-1898esomeprazole magnesiumEsomeprazoleWalgreen CompanyANDACurrent
0536-1131rugby esomeprazole magnesiumEsomeprazoleRugby LaboratoriesANDACurrent
0536-1131rugby esomeprazole magnesiumEsomeprazoleRugby LaboratoriesANDACurrent
11673-753Up and Up Esomeprazole Magnesiumesomeprazole magnesiumTarget CorporationANDACurrent
11673-753Up and Up Esomeprazole Magnesiumesomeprazole magnesiumTarget CorporationANDACurrent
11673-898up and up esomeprazole magnesiumEsomeprazoleTarget CorporationANDACurrent
11673-898up and up esomeprazole magnesiumEsomeprazoleTarget CorporationANDACurrent
11673-898up and up esomeprazole magnesiumEsomeprazoleTarget CorporationANDACurrent
11673-898up and up esomeprazole magnesiumEsomeprazoleTarget CorporationANDACurrent
11673-898up and up esomeprazole magnesiumEsomeprazoleTarget CorporationANDACurrent
11822-0024esomeprazole magnesiumesomeprazoleRite Aid CorporationANDACurrent
11822-0898esomeprazole magnesiumEsomeprazoleRite Aid CorporationANDACurrent
11822-0898esomeprazole magnesiumEsomeprazoleRite Aid CorporationANDACurrent
11822-0898esomeprazole magnesiumEsomeprazoleRite Aid CorporationANDACurrent
21130-088signature care esomeprazole magnesiumEsomeprazoleSafewayANDACurrent
21130-088signature care esomeprazole magnesiumEsomeprazoleSafewayANDACurrent
21130-088signature care esomeprazole magnesiumEsomeprazoleSafewayANDACurrent
21130-714signature care esomeprazole magnesiumesomeprazoleSafewayANDACurrent
30142-273esomeprazole magnesiumesomeprazoleKroger CompanyANDACurrent
30142-413esomeprazole magnesiumEsomeprazoleKroger CompanyANDACurrent
30142-413esomeprazole magnesiumEsomeprazoleKroger CompanyANDACurrent
36800-627topcare esomeprazole magnesiumesomeprazole magnesiumTopco Associates LLCANDACurrent
36800-627topcare esomeprazole magnesiumesomeprazole magnesiumTopco Associates LLCANDACurrent
36800-636Topcare Esomeprazole MagnesiumEsomeprazoleTopco Associates LLCANDACurrent
36800-636Topcare Esomeprazole MagnesiumEsomeprazoleTopco Associates LLCANDACurrent
36800-636Topcare Esomeprazole MagnesiumEsomeprazoleTopco Associates LLCANDACurrent
36800-636Topcare Esomeprazole MagnesiumEsomeprazoleTopco Associates LLCANDACurrent
37012-898esomeprazole magnesiumEsomeprazoleShopko Stores Operating Co., LLCANDACurrent
37012-898esomeprazole magnesiumEsomeprazoleShopko Stores Operating Co., LLCANDACurrent
37808-719Esomeprazole MagnesiumesomeprazoleH E BANDACurrent
37808-898esomeprazole magnesiumEsomeprazoleH E BANDACurrent
41163-539equaline esomeprazole magnesiumEsomeprazoleSupervalu IncANDACurrent
41163-539equaline esomeprazole magnesiumEsomeprazoleSupervalu IncANDACurrent
41163-539equaline esomeprazole magnesiumEsomeprazoleSupervalu IncANDACurrent
41163-539equaline esomeprazole magnesiumEsomeprazoleSupervalu IncANDACurrent
41190-898shoprite esomeprazole magnesiumEsomeprazoleWakefern Food CorporationANDACurrent
41190-898shoprite esomeprazole magnesiumEsomeprazoleWakefern Food CorporationANDACurrent
41250-727esomeprazole magnesiumesomeprazole magnesiumMeijer Distribution IncANDACurrent
41250-900esomeprazole magnesiumEsomeprazoleMeijer Distribution IncANDACurrent
41250-900esomeprazole magnesiumEsomeprazoleMeijer Distribution IncANDACurrent
41250-900esomeprazole magnesiumEsomeprazoleMeijer Distribution IncANDACurrent
41520-727careone esomeprazole magnesiumEsomeprazoleAmerican Sales CompanyANDACurrent
41520-727careone esomeprazole magnesiumEsomeprazoleAmerican Sales CompanyANDACurrent
46122-397Good Neighbor Pharmacy Esomeprazole MagnesiumEsomeprazoleAmerisource BergenANDACurrent
46122-397Good Neighbor Pharmacy Esomeprazole MagnesiumEsomeprazoleAmerisource BergenANDACurrent
46122-641Good Neighbor Pharmacy Esomeprazole MagnesiumesomeprazoleAmerisource BergenANDACurrent
46122-648good neighbor pharmacy esomeprazole magnesiumEsomeprazoleAmerisource BergenANDACurrent
49035-921equate esomeprazole magnesiumEsomeprazoleWal-Mart Stores IncANDACurrent
49035-921equate esomeprazole magnesiumEsomeprazoleWal-Mart Stores IncANDACurrent
49738-898smart sense esomeprazole magnesiumEsomeprazoleKmart CorporationANDACurrent
49738-898smart sense esomeprazole magnesiumEsomeprazoleKmart CorporationANDACurrent
50594-029sound body esomeprazole magnesiumEsomeprazoleBig Lots Stores, Inc.ANDACurrent
50594-029sound body esomeprazole magnesiumEsomeprazoleBig Lots Stores, Inc.ANDACurrent
50594-029sound body esomeprazole magnesiumEsomeprazoleBig Lots Stores, Inc.ANDACurrent
55301-898Exchange Select Esomeprazole MagnesiumEsomeprazoleArmy & Air Force Exchange ServiceANDACurrent
55301-898Exchange Select Esomeprazole MagnesiumEsomeprazoleArmy & Air Force Exchange ServiceANDACurrent
55301-898Exchange Select Esomeprazole MagnesiumEsomeprazoleArmy & Air Force Exchange ServiceANDACurrent
55316-898healthy accents esomeprazole magnesiumEsomeprazoleDZA Brands LLCANDACurrent
55316-898healthy accents esomeprazole magnesiumEsomeprazoleDZA Brands LLCANDACurrent
55319-898Family Wellness Esomeprazole MagnesiumEsomeprazoleFamily Dollar Services IncANDACurrent
55319-898Family Wellness Esomeprazole MagnesiumEsomeprazoleFamily Dollar Services IncANDACurrent
55910-250dg health esomeprazole magnesiumesomeprazoleDolgencorp, LLCANDACurrent
55910-250dg health esomeprazole magnesiumesomeprazoleDolgencorp, LLCANDACurrent
55910-593DG Health Esomeprazole MagnesiumEsomeprazoleDolgencorp, LLCANDACurrent
55910-593DG Health Esomeprazole MagnesiumEsomeprazoleDolgencorp, LLCANDACurrent
55910-593DG Health Esomeprazole MagnesiumEsomeprazoleDolgencorp, LLCANDACurrent
55910-593DG Health Esomeprazole MagnesiumEsomeprazoleDolgencorp, LLCANDACurrent
56062-898Esomeprazole MagnesiumEsomeprazolePublix Super Markets IncANDACurrent
62011-0332health mart esomeprazole magnesiumEsomeprazoleStrategic Sourcing Services LLCANDACurrent

Documents

DocumentTitleSubmission typeSubmission no.Date
658320SUPPL112021-01-06
658310SUPPL32021-01-06
495160ORIG12017-08-22
495080ORIG12017-08-22