FDA.reportPublic FDA data

Application 207740

Type
ANDA
Sponsor
DR REDDYS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207740-001OMEPRAZOLEOMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-05

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-05a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLEAMERISOURCEBERGEN DRUG CORPORATION0521c51b-d113-7e35-f1a6-c4495a2bcfcc2026-04-17WarningsExact identifier
application applno (ANDA): 207740
application number: ANDA207740
OmeprazoleOMEPRAZOLEWalmart Inc.5168ccd9-31b4-3a49-85b9-4f202cd99f6b2026-03-19WarningsExact identifier
application applno (ANDA): 207740
application number: ANDA207740
OmeprazoleOMEPRAZOLEChain Drug Marketing Association INC77d4f6c7-87ca-78bb-3310-2304a68f9f9b2025-01-17WarningsExact identifier
application applno (ANDA): 207740
application number: ANDA207740
OmeprazoleOMEPRAZOLEDr. Reddys Laboratories Inc4b3b389d-a151-d851-cb05-64eb49979e5e2024-12-19WarningsExact identifier
application applno (ANDA): 207740
application number: ANDA207740
ndc (product): 43598-286
OmeprazoleOMEPRAZOLEWalgreens Company5e2994fc-8f44-f6e4-71fe-44a215aa93a92024-11-10WarningsExact identifier
application applno (ANDA): 207740
application number: ANDA207740
ndc (product): 0363-1607
OmeprazoleOMEPRAZOLEDr. Reddys Laboratories Incb377cb0b-14b2-04bb-f276-fd69a257f9ca2024-11-10WarningsExact identifier
application applno (ANDA): 207740
application number: ANDA207740
ndc (product): 43598-841
OmeprazoleOMEPRAZOLEBluePoint Laboratoriesa86d52a5-15e2-012d-e053-2a95a90ac9122023-09-13WarningsExact identifier
application applno (ANDA): 207740
application number: ANDA207740
ndc (product): 68001-441

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

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