Application 202366

Type
ANDA
Sponsor
ZYDUS HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LANSOPRAZOLELANSOPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL15MGNoNo
002LANSOPRAZOLELANSOPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL30MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202366-001LANSOPRAZOLELANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19
A202366-002LANSOPRAZOLELANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A202366-001AB
A202366-002AB

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-1984e616aacf4f…
2026-09-14 22:38:342026-08A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-1984e616aacf4f…
2026-08-18 06:07:402026-07A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19caaa826d4ba7…
2026-08-18 06:07:402026-07A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-1974a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A202366-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A202366-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A202366-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202366-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202366-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202366-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202366-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202366-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202366-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202366-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202366-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202366-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202366-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202366-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202366-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202366-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202366-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202366-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202366-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202366-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202366-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202366-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202366-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202366-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202366-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202366-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202366-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202366-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202366-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202366-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202366-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202366-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202366-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202366-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202366-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202366-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202366-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202366-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202366-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202366-002AB174a2ff9319b5…

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 4 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LansoprazoleLANSOPRAZOLEGolden State Medical Supply, Inc.a9dd7e56-1aee-5f0b-e053-2995a90a43bf2024-12-23Warnings, Adverse reactionsName fallback
brand name: Lansoprazole
generic name: LANSOPRAZOLE
LansoprazoleLANSOPRAZOLEMacleods Pharmaceuticals Limited75691c2d-2265-4153-bc3a-4f7d5d51e2502024-12-02Warnings, Adverse reactionsName fallback
brand name: Lansoprazole
generic name: LANSOPRAZOLE
LANSOPRAZOLELANSOPRAZOLEZydus Lifesciences Limited76ffd38e-bea8-45a0-b6bd-82f0043ce64d2024-11-30Name fallback
brand name: LANSOPRAZOLE
generic name: LANSOPRAZOLE
LansoprazoleLANSOPRAZOLENuCare Pharmaceuticals,Inc.22f416bf-00f1-ceb9-e063-6394a90aa1dd2024-09-25Warnings, Adverse reactionsName fallback
brand name: Lansoprazole
generic name: LANSOPRAZOLE
LansoprazoleLANSOPRAZOLEMylan Pharmaceuticals Inc.c8fa7401-907f-41b6-a2e1-f4bc214f2cdf2024-09-15Warnings, Adverse reactionsName fallback
brand name: Lansoprazole
generic name: LANSOPRAZOLE
LansoprazoleLANSOPRAZOLEBryant Ranch Prepack8f0d3f2f-91d9-467a-a841-540664af80f92024-08-26Warnings, Adverse reactionsName fallback
brand name: Lansoprazole
generic name: LANSOPRAZOLE
LansoprazoleLANSOPRAZOLEBryant Ranch Prepacke07c7445-9652-4833-8b17-45c0124c4e5d2024-08-20Warnings, Adverse reactionsName fallback
brand name: Lansoprazole
generic name: LANSOPRAZOLE
LansoprazoleLANSOPRAZOLENorthStar Rx LLCac051296-6fe3-4ab5-a001-cc3e06199a222024-08-08Warnings, Adverse reactionsName fallback
brand name: Lansoprazole
generic name: LANSOPRAZOLE
LansoprazoleLANSOPRAZOLENuCare Pharmaceuticals,Inc.b12cca1c-da28-67e2-e053-2a95a90aaf6b2024-07-17Warnings, Adverse reactionsName fallback
brand name: Lansoprazole
generic name: LANSOPRAZOLE
Members Mark LansoprazoleLANSOPRAZOLESam's West Incfee84ce3-a884-4944-a32b-72e69a1229d42024-07-15WarningsName fallback
generic name: LANSOPRAZOLE
LansoprazoleLANSOPRAZOLENuCare Pharmaceuticals,Inc.9a277b9e-2e13-27c3-e053-2995a90a7ed52024-06-20Warnings, Adverse reactionsName fallback
brand name: Lansoprazole
generic name: LANSOPRAZOLE
Good Sense LansoprazoleLANSOPRAZOLEL. Perrigo Company91d69826-df5c-47a2-b852-3083629d18932024-06-17WarningsName fallback
generic name: LANSOPRAZOLE
LansoprazoleLANSOPRAZOLEDr.Reddys Laboratories Inc656bc92a-1f95-047d-cd27-724073e63fe62024-06-11Warnings, Adverse reactionsName fallback
brand name: Lansoprazole
generic name: LANSOPRAZOLE
LansoprazoleLANSOPRAZOLENuCare Pharmaceuticals,Inc.6d81faf7-aa59-429c-e053-2a91aa0a8bb22024-06-10Warnings, Adverse reactionsName fallback
brand name: Lansoprazole
generic name: LANSOPRAZOLE
LansoprazoleLANSOPRAZOLEAurobindo Pharma Limited1f2883d8-12db-40b7-9104-22a6690a22a72024-04-02Warnings, Adverse reactionsName fallback
brand name: Lansoprazole
generic name: LANSOPRAZOLE
LansoprazoleLANSOPRAZOLEMylan Pharmaceuticals Inc.20ff347c-ca18-497b-948d-1145035f2ffc2024-03-11Warnings, Adverse reactionsName fallback
brand name: Lansoprazole
generic name: LANSOPRAZOLE
LansoprazoleLANSOPRAZOLENuCare Pharmaceuticals,Inc.136ad992-2e39-dad9-e063-6294a90adcc62024-03-11Warnings, Adverse reactionsName fallback
brand name: Lansoprazole
generic name: LANSOPRAZOLE
LansoprazoleLANSOPRAZOLENuCare Pharmaceuticals,Inc.11344047-7ed4-61e7-e063-6394a90a332d2024-02-12Warnings, Adverse reactionsName fallback
brand name: Lansoprazole
generic name: LANSOPRAZOLE
LansoprazoleLANSOPRAZOLEBryant Ranch Prepacke0299cf2-8a8e-499b-a81e-16e844ea3aff2024-02-06Warnings, Adverse reactionsName fallback
brand name: Lansoprazole
generic name: LANSOPRAZOLE
LansoprazoleLANSOPRAZOLEBryant Ranch Prepackae03d05b-0a0f-4bae-bbdc-450b7b5f7a922024-01-10Warnings, Adverse reactionsName fallback
brand name: Lansoprazole
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 · 41 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-1945lansoprazolelansoprazoleA-S Medication SolutionsANDACurrent
50090-3195lansoprazolelansoprazoleA-S Medication SolutionsANDACurrent
50268-465lansoprazolelansoprazoleAvPAKANDACurrent
50268-465lansoprazolelansoprazoleAvPAKANDACurrent
50268-465lansoprazolelansoprazoleAvPAKANDACurrent
50268-466lansoprazolelansoprazoleAvPAKANDACurrent
50268-466lansoprazolelansoprazoleAvPAKANDACurrent
55700-616lansoprazolelansoprazoleLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-616lansoprazolelansoprazoleLake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-544lansoprazolelansoprazoleSt. Mary's Medical Park PharmacyANDACurrent
61919-655LANSOPRAZOLELANSOPRAZOLEDirect RXANDACurrent
61919-890LANSOPRAZOLELANSOPRAZOLEDirect RXANDACurrent
61919-890LANSOPRAZOLELANSOPRAZOLEDirect RXANDACurrent
61919-891LANSOPRAZOLELANSOPRAZOLEDIRECT RXANDACurrent
63629-5632lansoprazolelansoprazoleBryant Ranch PrepackANDACurrent
63629-5632lansoprazolelansoprazoleBryant Ranch PrepackANDACurrent
63629-7552lansoprazolelansoprazoleBryant Ranch PrepackANDACurrent
63629-7552lansoprazolelansoprazoleBryant Ranch PrepackANDACurrent
65841-769lansoprazolelansoprazoleCadila Healthcare LimitedANDACurrent
65841-769lansoprazolelansoprazoleCadila Healthcare LimitedANDACurrent
65841-769lansoprazolelansoprazoleZydus Lifesciences LimitedANDACurrent
65841-769lansoprazolelansoprazoleCadila Healthcare LimitedANDACurrent
65841-770lansoprazolelansoprazoleCadila Healthcare LimitedANDACurrent
65841-770lansoprazolelansoprazoleCadila Healthcare LimitedANDACurrent
65841-770lansoprazolelansoprazoleZydus Lifesciences LimitedANDACurrent
65841-770lansoprazolelansoprazoleCadila Healthcare LimitedANDACurrent
68071-3019lansoprazolelansoprazoleNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3019lansoprazolelansoprazoleNuCare Pharmaceuticals, Inc.ANDACurrent
68382-543lansoprazolelansoprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-543lansoprazolelansoprazoleZydus Pharmaceuticals USA Inc.ANDACurrent
68382-543lansoprazolelansoprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-544lansoprazolelansoprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-544lansoprazolelansoprazoleZydus Pharmaceuticals USA Inc.ANDACurrent
68382-544lansoprazolelansoprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68788-7385lansoprazolelansoprazolePreferred Pharmaceuticals Inc.ANDACurrent
68788-7385lansoprazolelansoprazolePreferred Pharmaceuticals Inc.ANDACurrent
68788-7385lansoprazolelansoprazolePreferred Pharmaceuticals Inc.ANDACurrent
68788-7385lansoprazolelansoprazolePreferred Pharmaceuticals Inc.ANDACurrent
68788-7385lansoprazolelansoprazolePreferred Pharmaceuticals Inc.ANDACurrent
71335-0105lansoprazolelansoprazoleBryant Ranch PrepackANDACurrent
71335-0105lansoprazolelansoprazoleBryant Ranch PrepackANDACurrent