FDA.reportPublic FDA data

Application 203306

Type
ANDA
Sponsor
NATCO PHARMA 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 43.

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
A203306-001LANSOPRAZOLELANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-13

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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-1384e616aacf4f…
2026-08-18 06:07:402026-07A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-133f01610625f2…
2019-09-15 20:21 UTC2019-09A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203306-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-01-13f41ea6bd6efb…

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 3 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
lansoprazoleLANSOPRAZOLEBryant Ranch Prepackbd278054-875e-4877-991c-cbdf3975f93e2025-03-31WarningsName fallback
brand name: lansoprazole
generic name: LANSOPRAZOLE
lansoprazoleLANSOPRAZOLEPadagis Israel Pharmaceuticals Ltd17f41872-f3d1-4b02-b6ce-0e731139495a2025-03-26WarningsName fallback
brand name: lansoprazole
generic name: LANSOPRAZOLE
equate lansoprazoleLANSOPRAZOLEWALMART INC.3a7aadbd-0a70-444f-95e1-cbde827818922025-03-14WarningsName fallback
generic name: LANSOPRAZOLE
dg health lansoprazoleLANSOPRAZOLEDolgencorp Ince6e3bcee-636f-4361-85f8-9ba5a0f3c7412025-03-04WarningsName fallback
generic name: LANSOPRAZOLE
LansoprazoleLANSOPRAZOLEQuallent Pharmaceuticals Health LLCcc006372-32d3-4539-921a-6bc9ec496b282025-02-28Warnings, Adverse reactionsName fallback
brand name: Lansoprazole
generic name: LANSOPRAZOLE
equaline lansoprazoleLANSOPRAZOLEUnited Natural Foods, Inc. dba UNFIbf8c337c-4a45-46e6-ae8e-46df80ca66e32025-02-13WarningsName fallback
generic name: LANSOPRAZOLE
lansoprazoleLANSOPRAZOLEPublix Super Markets Inc86a99ee3-0e98-46e8-8473-f8c812044a2f2025-02-13WarningsName fallback
brand name: lansoprazole
generic name: LANSOPRAZOLE
topcare lansoprazoleLANSOPRAZOLETopco Associates LLC73aec019-5337-48a4-b95c-993fff9cfc2a2025-02-13WarningsName fallback
generic name: LANSOPRAZOLE
Kirkland Signature LansoprazoleLANSOPRAZOLECostco Wholesale Company326aabe6-c4ac-4bca-949f-38015dcbaf4e2025-02-12WarningsName fallback
generic name: LANSOPRAZOLE
lansoprazoleLANSOPRAZOLEKroger Company4c0684b5-5c18-4ed5-8185-8b5d51dce3a02025-02-08WarningsName fallback
brand name: lansoprazole
generic name: LANSOPRAZOLE
LansoprazoleLANSOPRAZOLECVS Pharmacy992a8f95-475c-4e57-90cc-9839c86784272025-02-08WarningsName fallback
brand name: Lansoprazole
generic name: LANSOPRAZOLE
topcare LansoprazoleLANSOPRAZOLETopco Associates LLCec5d6d5c-11e7-4932-a48f-fb72218ceccd2025-02-08WarningsName fallback
generic name: LANSOPRAZOLE
basic care lansoprazoleLANSOPRAZOLEAmazon.com Services LLC6b57eb00-74fd-435f-bd08-086c9f8ac62c2025-02-05WarningsName fallback
generic name: LANSOPRAZOLE
Good Sense LansoprazoleLANSOPRAZOLEL. Perrigo Companyd86585b7-e146-4f04-9016-412b16e06f552025-01-29WarningsName fallback
generic name: LANSOPRAZOLE
basic care lansoprazoleLANSOPRAZOLEAmazon.com Services LLCf39feec2-54fb-47d4-9b45-08f75e92117e2025-01-24WarningsName fallback
generic name: LANSOPRAZOLE
LansoprazoleLANSOPRAZOLEAmerican Health Packagingdee80a19-e514-41e6-9153-c959699d97b12025-01-07Warnings, Adverse reactionsName fallback
brand name: Lansoprazole
generic name: LANSOPRAZOLE
LansoprazoleLANSOPRAZOLENuCare Pharmaceuticals,Inc.1c364fc5-eb43-b12f-e063-6294a90a43192025-01-02Warnings, Adverse reactionsName fallback
brand name: Lansoprazole
generic name: LANSOPRAZOLE
LansoprazoleLANSOPRAZOLENuCare Pharmaceuticals,Inc.1bbb8f3a-80bf-b881-e063-6294a90ab4f22025-01-02Warnings, Adverse reactionsName fallback
brand name: Lansoprazole
generic name: LANSOPRAZOLE
Lansoprazole DRLANSOPRAZOLEAdvanced Rx Pharmacy of Tennessee, LLCce1a4f32-da65-29d3-e053-2995a90a42ee2024-12-31Warnings, Adverse reactionsName fallback
generic name: LANSOPRAZOLE
Lansoprazole DRLANSOPRAZOLEAdvanced Rx Pharmacy of Tennessee, LLCc77da981-9260-fabd-e053-2a95a90aa71c2024-12-31Warnings, Adverse reactionsName fallback
generic name: LANSOPRAZOLE

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-2448LansoprazoleLansoprazoleActavis Pharma, Inc.ANDACurrent
16571-742LansoprazoleLansoprazoleRising Pharma Holdings, Inc.ANDACurrent
37808-448LansoprazoleLansoprazoleHEBANDACurrent
37808-448LansoprazoleLansoprazoleHEBANDACurrent
37808-448LansoprazoleLansoprazoleHEBANDACurrent
37808-448LansoprazoleLansoprazoleHEBANDACurrent
68016-756LansoprazoleLansoprazoleChain Drug Consortium, LLCANDACurrent
68016-756LansoprazoleLansoprazoleChain Drug Consortium, LLCANDACurrent
68016-756LansoprazoleLansoprazoleChain Drug Consortium, LLCANDACurrent