FDA.reportPublic FDA data

Application 078878

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMEPRAZOLE MAGNESIUMOMEPRAZOLE MAGNESIUMCAPSULE, DELAYED RELEASE;ORALEQ 20MG BASENoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0179-8104Omeprazole MagnesiumOmeprazole MagnesiumKaiser PermanenteANDACurrent
0179-8104Omeprazole MagnesiumOmeprazole MagnesiumKaiser PermanenteANDACurrent
0363-0042Omeprazole MagnesiumOmeprazole MagnesiumWalgreens CompanyANDACurrent
11673-397Omeprazole MagnesiumOmeprazole Magnesium 20.6mg CapsulesTarget CorporationANDACurrent
21130-398Omeprazole MagnesiumOmeprazole MagnesiumAlbertsons CompaniesANDACurrent
30142-012Omeprazole MagnesiumOmeprazole Magnesium 20.6mg CapsulesThe Kroger Co.ANDACurrent
37808-006Omeprazole MagnesiumOmeprazole MagnesiumHEBANDACurrent
37835-891Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMBi-MartANDACurrent
41250-064Omeprazole MagnesiumOmeprazole MagnesiumMeijer Distribution IncANDACurrent
43598-813Omeprazole MagnesiumOmeprazole MagnesiumDr. Reddy's Laboratories Inc.ANDACurrent
49035-397Omeprazole MagnesiumOmeprazole Magnesium 20.6mg CapsulesWal-Mart Stores IncANDACurrent
53943-520Omeprazole MagnesiumOmeprazole MagnesiumDiscount Drug Mart, IncANDACurrent
53943-520Omeprazole MagnesiumOmeprazole MagnesiumDiscount Drug Mart, IncANDACurrent
55111-397Omeprazole MagnesiumOmeprazole MagnesiumDr. Reddy's Laboratories LimitedANDACurrent
55111-397Omeprazole MagnesiumOmeprazole MagnesiumDr. Reddy's Laboratories LimitedANDACurrent
55111-397Omeprazole MagnesiumOmeprazole MagnesiumDr. Reddy's Laboratories LimitedANDACurrent
55315-367Omeprazole MagnesiumOmeprazole MagnesiumFREDSANDACurrent
55315-368Omeprazole MagnesiumOmeprazole MagnesiumFREDSANDACurrent
55319-916Omeprazole MagnesiumOmeprazole MagnesiumFamily Dollar Stores, Inc.ANDACurrent
57896-759Omeprazole MagnesiumOmeprazole MagnesiumGericare PharmaceuticalsANDACurrent
57896-759Omeprazole MagnesiumOmeprazole MagnesiumGericare PharmaceuticalsANDACurrent
59450-012Omeprazole MagnesiumOmeprazole Magnesium 20.6mg CapsulesThe Kroger Co.ANDACurrent
59450-012Omeprazole MagnesiumOmeprazole Magnesium 20.6mg CapsulesThe Kroger Co.ANDACurrent
63868-177Omeprazole MagnesiumOmeprazole MagnesiumChain Drug Marketing AssociationANDACurrent
68016-759OmeprazoleOmeprazoleChain Drug Consortium, LLCANDACurrent
68016-759OmeprazoleOmeprazoleChain Drug Consortium, LLCANDACurrent
68016-760Omeprazole MagnesiumOmeprazole MagnesiumChain Drug Consortium, LLCANDACurrent
69618-047OmeprazoleOmeprazoleReliable 1 Laboratories LLCANDACurrent
69618-047OmeprazoleOmeprazoleReliable 1 Laboratories LLCANDACurrent
69618-047OmeprazoleOmeprazoleReliable 1 Laboratories LLCANDACurrent
69842-027Omeprazole MagnesiumOmeprazole MagnesiumCVS Health Corp.ANDACurrent
70000-0232Acid ReducerOmeprazole MagnesiumCardinal HealthANDACurrent
70000-0232Acid ReducerOmeprazole MagnesiumCardinal HealthANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43150ORIG2013-05-10