Application 211571

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMTABLET, DELAYED RELEASE;ORALEQ 20MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0305Esomeprazole MagnesiumEsomeprazole MagnesiumWalgreens CompanyANDACurrent
30142-556Esomeprazole MagnesiumEsomeprazole MagnesiumThe Kroger Co.ANDACurrent
43598-469Esomeprazole MagnesiumEsomeprazole MagnesiumDr. Reddys Laboratories IncANDACurrent
69842-099Esomeprazole MagnesiumEsomeprazole MagnesiumCVS Health CorpANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63421ORIG2020-06-04