FDA.reportPublic FDA data

Application 075347

Type
ANDA
Sponsor
ACTAVIS LABS FL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMEPRAZOLEOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL10MGNoNo
002OMEPRAZOLEOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL20MGNoNo
003OMEPRAZOLEOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL40MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075347-001OMEPRAZOLEOMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-30
A075347-002OMEPRAZOLEOMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-30
A075347-003OMEPRAZOLEOMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A075347-001AB
A075347-002AB
A075347-003AB

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075347-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-3084e616aacf4f…
2026-09-14 22:38:342026-08A075347-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-3084e616aacf4f…
2026-09-14 22:38:342026-08A075347-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-3084e616aacf4f…
2026-08-18 06:07:402026-07A075347-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-30caaa826d4ba7…
2026-08-18 06:07:402026-07A075347-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-30caaa826d4ba7…
2026-08-18 06:07:402026-07A075347-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075347-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075347-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075347-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075347-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075347-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075347-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A075347-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075347-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075347-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075347-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075347-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075347-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075347-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075347-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075347-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075347-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075347-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075347-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075347-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075347-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075347-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075347-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075347-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075347-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075347-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075347-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075347-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075347-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A075347-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A075347-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075347-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075347-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075347-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075347-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2008-05-30301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-09-29 23:25 UTC2022-09A075347-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A075347-002AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A075347-003AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075347-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075347-002AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075347-003AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075347-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075347-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075347-003AB1a50c72e98297…

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 15 · 287 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
omeprazoleOMEPRAZOLERite Aid Corporation28a0b4c8-3ad3-451c-a957-28aef5e3d8b52026-09-09WarningsName fallback
brand name: omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEAmazon.com Services LLC94faa721-e925-4033-8661-d1990dfa920d2026-08-30WarningsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEREMEDYREPACK INC.63b3982a-b541-4b0d-99d4-93a673e57d462026-08-28Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
AMAZON BASIC CARE OMEPRAZOLEOMEPRAZOLEAmazon.com Services LLC10efef7c-bdf4-36cf-e063-6394a90a8c0f2026-08-28WarningsName fallback
generic name: OMEPRAZOLE
good now omeprazoleOMEPRAZOLEGobrands, Inc0e7c4aee-2c9f-4d5c-9d47-c333bf00ba9f2026-08-19WarningsName fallback
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEDiscount Drug Mart, Inc4d5f30c2-775d-a1a3-e063-6394a90a07ff2026-08-12WarningsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OMEPRAZOLEOMEPRAZOLEH E B4eb05eb3-be59-4132-95a8-5a8f5065d7582026-08-10WarningsName fallback
brand name: OMEPRAZOLE
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEREMEDYREPACK INC.ded0df8b-1813-4595-ac2b-5499704bfd482026-08-05Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEA-S Medication Solutions6ea9a6f3-b756-4cdf-b3db-f666a2c17d662026-08-04Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEProficient Rx LP062800b1-790a-41c3-a8be-94143d2c7fb62026-08-01Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEPD-Rx Pharmaceuticals, Inc.96104ea6-c08f-40b5-83f5-d840b317f1fd2026-07-31Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEREMEDYREPACK INC.a19ce586-59b7-4c2e-9e8d-12e8f0f058e22026-07-21Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEPD-Rx Pharmaceuticals, Inc.0344268f-d8e6-48d5-b1e1-f750ed1d8a522026-07-17Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEP & L Development, LLC883e428a-e157-4bbf-8657-e7a93dc99e8c2026-07-14WarningsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEWALMART INC. (see also Equate)d3c1ba08-680d-4e39-875c-1f1d42ae787c2026-07-13WarningsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEHAWAII REPACK, INC.9359e826-5263-44fc-8dd3-9d0852fe42d62026-07-13Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEBryant Ranch Prepackdcaadc8c-32d1-476f-b821-973c012b7fa72026-07-10Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
careone omeprazoleOMEPRAZOLEAmerican Sales Company5b88717a-e90c-4e74-ae2a-29270e14a3cc2026-07-08WarningsName fallback
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLE MAGNESIUMYYBA CORP535c2543-84f3-f5c1-e063-6394a90adb1e2026-07-07WarningsName fallback
brand name: Omeprazole
OmeprazoleOMEPRAZOLESt. Mary's Medical Park Pharmacy4c0cf466-f9e8-390e-e063-6294a90a2ed82026-07-02Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60429-899OmeprazoleOmeprazoleGolden State Medical Supply, Inc.ANDACurrent
64205-620OmeprazoleOmeprazoleReadyMedsANDACurrent
64205-640OmeprazoleOmeprazoleReadyMedsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42981ORIG2004-12-07
8627ORIG2004-06-10
30857ORIG2001-11-16