Home Applications 209339 Application 209339
Type ANDA
Sponsor AUROBINDO PHARMA LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE;ORAL EQ 20MG BASE No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209339-001 ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2017-10-16
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 A209339-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2017-10-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209339-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2017-10-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209339-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2017-10-16 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209339-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2017-10-16 a50c72e98297…
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 · 20 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Aurohealth LLC d0733d37-cc9c-41ba-9c5f-a0f8bf5a2364 2026-05-27 Warnings Exact identifier application applno (ANDA): 209339 application number: ANDA209339 ndc (product): 58602-846 Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM YYBA CORP 4a7f3a55-862f-111f-e063-6294a90a6a44 2026-02-10 Warnings Exact identifier application applno (ANDA): 209339 application number: ANDA209339 Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM LEADER/ CARDINAL HEALTH 110, INC. aef20ccb-1eb7-4c79-af8e-81220eb73752 2025-11-18 Warnings Exact identifier application applno (ANDA): 209339 application number: ANDA209339 Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Aurohealth LLC 212cca98-786f-4677-b687-fff81a1dd59f 2025-11-14 Warnings Exact identifier application applno (ANDA): 209339 application number: ANDA209339 Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Amerisource Bergen 3c6c2fd5-1a0f-44f7-8d02-c9bc26b8db46 2025-08-30 Warnings Exact identifier application applno (ANDA): 209339 application number: ANDA209339 Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Aurohealth LLC b594f052-b6be-4d3b-9316-29cab050344a 2025-05-20 Warnings Exact identifier application applno (ANDA): 209339 application number: ANDA209339 ndc (product): 58602-809 ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM LEADER/ CARDINAL HEALTH 110, INC. c98b4332-ce47-422e-be54-f3eee0762354 2025-04-24 Warnings Exact identifier application applno (ANDA): 209339 application number: ANDA209339 Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Aurohealth LLC 5647bfb0-6af0-4580-b202-0f1fc9c41265 2025-03-13 Warnings Exact identifier application applno (ANDA): 209339 application number: ANDA209339 Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Publix c45fd180-9d81-41e0-b7f8-025b8f29763a 2025-02-21 Warnings Exact identifier application applno (ANDA): 209339 application number: ANDA209339 ndc (product): 56062-020 Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM CVS Pharmacy, Inc. d226cda0-5cdb-4e2d-a865-530a8f09a095 2024-04-27 Warnings Exact identifier application applno (ANDA): 209339 application number: ANDA209339 ndc (product): 69842-248 Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM INNOVUS PHARMACEUTICALS, INC. a32039b7-8475-4ec5-abaf-07f9aee3954b 2024-04-27 Warnings Exact identifier application applno (ANDA): 209339 application number: ANDA209339 Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Family Dollar Stores, LLC f86ba9b5-736e-b279-e053-6394a90acf7c 2024-04-27 Warnings Exact identifier application applno (ANDA): 209339 application number: ANDA209339 Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Ahold U.S.A., Inc, 7bb719a0-9836-6752-e053-2a91aa0a2f48 2024-04-27 Warnings Exact identifier application applno (ANDA): 209339 application number: ANDA209339 ndc (product): 60000-109 Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Better Living Brands LLC ee6e3f66-4eb9-4094-afcc-aaa020942b39 2024-04-27 Warnings Exact identifier application applno (ANDA): 209339 application number: ANDA209339 ndc (product): 21130-100 Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Best Choice 56120925-28e3-4e6c-b54d-490d7460984f 2024-04-27 Warnings Exact identifier application applno (ANDA): 209339 application number: ANDA209339 ndc (product): 63941-971 Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM WALGREEN CO. f9e10472-c6a3-402c-b6a2-f8700ad73e9f 2024-04-27 Warnings Exact identifier application applno (ANDA): 209339 application number: ANDA209339 ndc (product): 0363-0508 Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Aurohealth LLC f9a5431a-ea03-441f-9064-6e7f30b61674 2024-04-27 Warnings Exact identifier application applno (ANDA): 209339 application number: ANDA209339 ndc (product): 58602-822 Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Wal-Mart Stores, Inc. c14f096d-ea1f-4539-8ad0-bb9907745cfc 2024-04-27 Warnings Exact identifier application applno (ANDA): 209339 application number: ANDA209339 ndc (product): 49035-980 Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Amerisource Bergen c94eb997-07d4-4d2e-b213-9a0d51db41c0 2024-03-29 Warnings Exact identifier application applno (ANDA): 209339 application number: ANDA209339 Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Retail Business Services, LLC. ce376d91-0ea8-4922-9f7f-707420cb1d96 2021-03-12 Warnings Exact identifier application applno (ANDA): 209339 application number: ANDA209339
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 2 · 86 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0363-0508 Esomeprazole Magnesium Esomeprazole Magnesium WALGREEN CO. ANDA Current 0363-0508 Esomeprazole Magnesium Esomeprazole Magnesium WALGREEN CO. ANDA Current 0363-0508 Esomeprazole Magnesium Esomeprazole Magnesium WALGREEN CO. ANDA Current 0363-0508 Esomeprazole Magnesium Esomeprazole Magnesium WALGREEN CO. ANDA Current 0363-0508 Esomeprazole Magnesium Esomeprazole Magnesium WALGREEN CO. ANDA Current 0363-0508 Esomeprazole Magnesium Esomeprazole Magnesium WALGREEN CO. ANDA Current 21130-100 Esomeprazole Magnesium Esomeprazole Magnesium Better Living Brands LLC ANDA Current 21130-100 Esomeprazole Magnesium Esomeprazole Magnesium Better Living Brands LLC ANDA Current 46122-538 Esomeprazole Magnesium Esomeprazole Magnesium Amerisource Bergen ANDA Current 46122-538 Esomeprazole Magnesium Esomeprazole Magnesium Amerisource Bergen ANDA Current 46122-538 Esomeprazole Magnesium Esomeprazole Magnesium Amerisource Bergen ANDA Current 46122-538 Esomeprazole Magnesium Esomeprazole Magnesium Amerisource Bergen ANDA Current 49035-980 Esomeprazole Magnesium Esomeprazole Magnesium Wal-Mart Stores, Inc. ANDA Current 49035-980 Esomeprazole Magnesium Esomeprazole Magnesium Wal-Mart Stores, Inc. ANDA Current 49035-980 Esomeprazole Magnesium Esomeprazole Magnesium Wal-Mart Stores, Inc. ANDA Current 49035-980 Esomeprazole Magnesium Esomeprazole Magnesium Wal-Mart Stores, Inc. ANDA Current 49035-980 Esomeprazole Magnesium Esomeprazole Magnesium Wal-Mart Stores, Inc. ANDA Current 50066-923 GENOZOL Esomeprazole Magnesium Genomma Lab USA Inc ANDA Current 50066-923 GENOZOL Esomeprazole Magnesium Genomma Lab USA Inc ANDA Current 50066-923 GENOZOL Esomeprazole Magnesium Genomma Lab USA Inc ANDA Current 50066-923 GENOZOL Esomeprazole Magnesium Genomma Lab USA Inc ANDA Current 50066-923 GENOZOL Esomeprazole Magnesium Genomma Lab USA Inc ANDA Current 53943-890 Esomeprazole Magnesium Esomeprazole Magnesium DISCOUNT DRUG MART ANDA Current 53943-890 Esomeprazole Magnesium Esomeprazole Magnesium DISCOUNT DRUG MART ANDA Current 53943-890 Esomeprazole Magnesium Esomeprazole Magnesium DISCOUNT DRUG MART ANDA Current 53943-890 Esomeprazole Magnesium Esomeprazole Magnesium DISCOUNT DRUG MART ANDA Current 55315-010 Esomeprazole Magnesium Esomeprazole Magnesium Fred's, Inc. ANDA Current 55315-010 Esomeprazole Magnesium Esomeprazole Magnesium Fred's, Inc. ANDA Current 55315-010 Esomeprazole Magnesium Esomeprazole Magnesium Fred's, Inc. ANDA Current 55319-988 Esomeprazole Magnesium Esomeprazole Magnesium Family Dollar, Inc. ANDA Current 55319-988 Esomeprazole Magnesium Esomeprazole Magnesium Family Dollar, Inc. ANDA Current 55319-988 Esomeprazole Magnesium Esomeprazole Magnesium Family Dollar, Inc. ANDA Current 55319-988 Esomeprazole Magnesium Esomeprazole Magnesium Family Dollar, Inc. ANDA Current 55910-016 Esomeprazole Magnesium Esomeprazole Magnesium Dolgencorp, LLC ANDA Current 55910-016 Esomeprazole Magnesium Esomeprazole Magnesium Dolgencorp, LLC ANDA Current 55910-016 Esomeprazole Magnesium Esomeprazole Magnesium Dolgencorp, LLC ANDA Current 55910-016 Esomeprazole Magnesium Esomeprazole Magnesium Dolgencorp, LLC ANDA Current 56062-020 Esomeprazole Magnesium Esomeprazole Magnesium Publix ANDA Current 56062-020 Esomeprazole Magnesium Esomeprazole Magnesium Publix ANDA Current 56062-020 Esomeprazole Magnesium Esomeprazole Magnesium Publix ANDA Current 58602-809 Esomeprazole Magnesium Esomeprazole Magnesium Aurohealth LLC ANDA Current 58602-809 Esomeprazole Magnesium Esomeprazole Magnesium Aurohealth LLC ANDA Current 58602-809 Esomeprazole Magnesium Esomeprazole Magnesium Aurohealth LLC ANDA Current 58602-809 Esomeprazole Magnesium Esomeprazole Magnesium Aurohealth LLC ANDA Current 58602-809 Esomeprazole Magnesium Esomeprazole Magnesium Aurohealth LLC ANDA Current 58602-809 Esomeprazole Magnesium Esomeprazole Magnesium Aurohealth LLC ANDA Current 58602-809 Esomeprazole Magnesium Esomeprazole Magnesium Aurohealth LLC ANDA Current 58602-822 Esomeprazole Magnesium Esomeprazole Magnesium Aurohealth LLC ANDA Current 58602-822 Esomeprazole Magnesium Esomeprazole Magnesium Aurohealth LLC ANDA Current 58602-822 Esomeprazole Magnesium Esomeprazole Magnesium Aurohealth LLC ANDA Current 58602-822 Esomeprazole Magnesium Esomeprazole Magnesium Aurohealth LLC ANDA Current 58602-822 Esomeprazole Magnesium Esomeprazole Magnesium Aurohealth LLC ANDA Current 58602-846 Esomeprazole Magnesium Esomeprazole Magnesium Aurohealth LLC ANDA Current 58602-846 Esomeprazole Magnesium Esomeprazole Magnesium Aurohealth LLC ANDA Current 58602-846 Esomeprazole Magnesium Esomeprazole Magnesium Aurohealth LLC ANDA Current 60000-109 Esomeprazole Magnesium Esomeprazole Magnesium Ahold U.S.A., Inc, ANDA Current 60000-109 Esomeprazole Magnesium Esomeprazole Magnesium Ahold U.S.A., Inc, ANDA Current 60000-109 Esomeprazole Magnesium Esomeprazole Magnesium Ahold U.S.A., Inc, ANDA Current 62011-0402 Esomeprazole Magnesium Esomeprazole Magnesium McKESSON Corporation ANDA Current 63941-971 Esomeprazole Magnesium Esomeprazole Magnesium Best Choice ANDA Current 63941-971 Esomeprazole Magnesium Esomeprazole Magnesium Best Choice ANDA Current 63941-971 Esomeprazole Magnesium Esomeprazole Magnesium Best Choice ANDA Current 63941-971 Esomeprazole Magnesium Esomeprazole Magnesium Best Choice ANDA Current 68016-007 Esomeprazole Magnesium Esomeprazole Magnesium Chain Drug Consortium, LLC ANDA Current 68016-007 Esomeprazole Magnesium Esomeprazole Magnesium Chain Drug Consortium, LLC ANDA Current 68016-007 Esomeprazole Magnesium Esomeprazole Magnesium Chain Drug Consortium, LLC ANDA Current 68016-007 Esomeprazole Magnesium Esomeprazole Magnesium Chain Drug Consortium, LLC ANDA Current 68196-977 Esomeprazole Magnesium Esomeprazole Magnesium Sam's West Inc ANDA Current 68196-977 Esomeprazole Magnesium Esomeprazole Magnesium Sam's West Inc ANDA Current 68196-977 Esomeprazole Magnesium Esomeprazole Magnesium Sam's West Inc ANDA Current 68196-977 Esomeprazole Magnesium Esomeprazole Magnesium Sam's West Inc ANDA Current 68196-977 Esomeprazole Magnesium Esomeprazole Magnesium Sam's West Inc ANDA Current 69842-248 Esomeprazole Magnesium Esomeprazole Magnesium CVS Pharmacy, Inc. ANDA Current 69842-248 Esomeprazole Magnesium Esomeprazole Magnesium CVS Pharmacy, Inc. ANDA Current 69842-248 Esomeprazole Magnesium Esomeprazole Magnesium CVS Pharmacy, Inc. ANDA Current 69842-248 Esomeprazole Magnesium Esomeprazole Magnesium CVS Pharmacy, Inc. ANDA Current 69842-248 Esomeprazole Magnesium Esomeprazole Magnesium CVS Pharmacy, Inc. ANDA Current 70677-0069 Esomeprazole Magnesium Esomeprazole Magnesium McKESSON Corporation ANDA Current 72036-800 Esomeprazole Magnesium Esomeprazole Magnesium Harris Teeter ANDA Current 72036-800 Esomeprazole Magnesium Esomeprazole Magnesium Harris Teeter ANDA Current