FDA.reportPublic FDA data

Application 202194

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LANSOPRAZOLELANSOPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL15MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A202194-001LANSOPRAZOLELANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LansoprazoleLANSOPRAZOLEDr. Reddy's Laboratories Inc.4a701c0d-fef5-aa12-01e6-e3680a161a7d2026-07-21WarningsExact identifier
application applno (ANDA): 202194
application number: ANDA202194
ndc (product): 43598-109
LansoprazoleLANSOPRAZOLERugby Laboratories, Incaa95216c-8985-d160-1743-ba168a35177f2026-07-17WarningsExact identifier
application applno (ANDA): 202194
application number: ANDA202194
ndc (product): 0536-1368
LansoprazoleLANSOPRAZOLEDr. Reddy's Laboratories Inc.a24acc0b-7770-1087-77bd-048259a5bf722026-07-15WarningsExact identifier
application applno (ANDA): 202194
application number: ANDA202194
ndc (product): 43598-161
LansoprazoleLANSOPRAZOLELEADER/ Cardinal Health 110, Inc.486838cd-17ee-c2df-4e05-aa6106dd8fd82026-07-15WarningsExact identifier
application applno (ANDA): 202194
application number: ANDA202194
ndc (product): 70000-0612
LansoprazoleLANSOPRAZOLEDr. Reddy's Laboratories Limited15e05eda-48aa-a4b7-4b8a-4ee1cf1101202026-07-09WarningsExact identifier
application applno (ANDA): 202194
application number: ANDA202194
ndc (product): 55111-739
LansoprazoleLANSOPRAZOLEAMERISOURCEBERGEN DRUG CORPORATIONaccb92e8-dd14-b87b-c20a-6c4803815bc22026-04-17WarningsExact identifier
application applno (ANDA): 202194
application number: ANDA202194
LansoprazoleLANSOPRAZOLEChain Drug Marketing Association74417c65-cccd-5a6a-0f96-0d8cb5a1592a2025-07-18WarningsExact identifier
application applno (ANDA): 202194
application number: ANDA202194
LansoprazoleLANSOPRAZOLEWalgreens company277093d5-cd0f-36ad-63d4-824a62d2a16c2025-07-18WarningsExact identifier
application applno (ANDA): 202194
application number: ANDA202194

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0739LansoprazoleLansoprazoleWalgreen CoANDACurrent
0363-0739LansoprazoleLansoprazoleWalgreen CoANDACurrent
0363-0739LansoprazoleLansoprazoleWalgreen CoANDACurrent
0536-1324LansoprazoleLansoprazoleRugby LaboratoriesANDACurrent
0536-1368LansoprazoleLansoprazoleRugby Laboratories, IncANDACurrent
11822-0016LansoprazoleLansoprazoleRite Aid CorporationANDACurrent
11822-0019LansoprazoleLansoprazoleRite Aid CorporationANDACurrent
11822-0019LansoprazoleLansoprazoleRite Aid CorporationANDACurrent
21130-046LansoprazoleLansoprazoleAlbertsons CompaniesANDACurrent
30142-288LansoprazoleLansoprazoleKroger CompanyANDACurrent
30142-983LansoprazoleLansoprazoleKroger CompanyANDACurrent
43598-109LansoprazoleLansoprazoleDr. Reddy's Laboratories Inc.ANDACurrent
43598-109LansoprazoleLansoprazoleDr. Reddy's Laboratories Inc.ANDACurrent
43598-161LansoprazoleLansoprazoleDr. Reddy's Laboratories Inc.ANDACurrent
43598-883LansoprazoleLansoprazoleDr. Reddy's Laboratories Inc.ANDACurrent
49035-739LansoprazoleLansoprazoleWal-Mart Stores IncANDACurrent
49035-739LansoprazoleLansoprazoleWal-Mart Stores IncANDACurrent
49035-739LansoprazoleLansoprazoleWal-Mart Stores IncANDACurrent
51316-006LansoprazoleLansoprazoleCVS Pharmacy, IncANDACurrent
55111-739LansoprazoleLansoprazoleDr. Reddy's Laboratories LimitedANDACurrent
55111-739LansoprazoleLansoprazoleDr. Reddy's Laboratories LimitedANDACurrent
55111-739LansoprazoleLansoprazoleDr. Reddy's Laboratories LimitedANDACurrent
57896-761LansoprazoleLansoprazoleGericare PharmaceuticalsANDACurrent
63868-429LansoprazoleLansoprazoleChain Drug Marketing AssociationANDACurrent
69618-055LansoprazoleLansoprazoleReliable 1 LaboratoriesANDACurrent
69842-270LansoprazoleLansoprazoleCVS Health CorpANDACurrent
70000-0069LansoprazoleLansoprazoleCardinal HealthANDACurrent
70000-0069LansoprazoleLansoprazoleCardinal HealthANDACurrent
70000-0612LansoprazoleLansoprazoleCardinal HealthANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43388ORIG2014-01-17
9989ORIG2012-05-22