FDA.reportPublic FDA data

Application 207740

Type
ANDA
Sponsor
DR REDDYS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMEPRAZOLEOMEPRAZOLETABLET, DELAYED RELEASE;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-1607OmeprazoleOmeprazoleWalgreens CompanyANDACurrent
21130-018OmeprazoleOmeprazoleAlbertsons CompaniesANDACurrent
43598-286OmeprazoleOmeprazoleDr. Reddys Laboratories IncANDACurrent
43598-286OmeprazoleOmeprazoleDr. Reddys Laboratories IncANDACurrent
43598-841OmeprazoleOmeprazoleDr. Reddys Laboratories IncANDACurrent
43598-841OmeprazoleOmeprazoleDr. Reddys Laboratories IncANDACurrent
57896-960OmeprazoleOmeprazoleGERICARE PHARMACEUTICALSANDACurrent
57896-960OmeprazoleOmeprazoleGERICARE PHARMACEUTICALSANDACurrent
63868-471OmeprazoleOmeprazoleChain Drug Marketing Association INCANDACurrent
63868-471OmeprazoleOmeprazoleChain Drug Marketing Association INCANDACurrent
68001-441OmeprazoleOmeprazoleBluePoint LaboratoriesANDACurrent
68001-441OmeprazoleOmeprazoleBluePoint LaboratoriesANDACurrent
71713-201OmeprazoleOmeprazoleThirty Madison IncANDACurrent
71713-201OmeprazoleOmeprazoleThirty Madison IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55242ORIG2018-11-15