FDA.reportPublic FDA data

Application 018972

Type
NDA
Sponsor
WYETH PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CORDARONEAMIODARONE HYDROCHLORIDETABLET;ORAL200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

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
N018972-001CORDARONEAMIODARONE HYDROCHLORIDE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-24

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 22:38:342026-08N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-2484e616aacf4f…
2026-08-18 06:07:402026-07N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018972-001CORDARONE200MGTABLET / ORALRLD1985-12-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018972-001CORDARONE200MGTABLET / ORALRLD1985-12-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET / ORALRLD1985-12-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET / ORALRLD1985-12-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET / ORALRLD1985-12-2487673890dc5c…
2021-03-12 10:30 UTC2021-03N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET / ORALRLD1985-12-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET / ORALRLD1985-12-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET / ORALRLD1985-12-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET / ORALRLD1985-12-243f01610625f2…
2019-09-15 20:21 UTC2019-09N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET / ORALRLD1985-12-24b00525d2431f…
2019-07-19 19:46 UTC2019-07N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET / ORALRLD1985-12-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-243f0d92c62455…
2023-05-13 08:27 UTC2023-05N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-24053a50430f4f…
2023-01-26 05:58 UTC2023-01N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018972-001CORDARONE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-24f41ea6bd6efb…

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 2 of 3 · 49 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEAdvagen Pharma Limitedd911b4cf-eec4-43f8-aa64-cc60cfc901b92025-12-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEChartwell RX, LLC5520f11d-968d-4f4f-bf57-d14369c0d7462025-12-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEAmerican Health Packagingd912a75a-ddac-4e7b-b5c4-321d4252ec052025-11-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
PaceroneAMIODARONE HYDROCHLORIDEBryant Ranch Prepackdcadce9c-d0a0-4235-8ff8-dd93c09e03b32025-11-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDEHenry Schein, Inc.0c9ee15a-5741-4aaa-8d80-c7bd2e45822e2025-10-29Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEMedical Purchasing Solutions, LLC.4240b2e9-be05-3de5-e063-6394a90a4bb22025-10-28Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
PaceroneAMIODARONE HYDROCHLORIDEUpsher-Smith Laboratories, LLC4c4ec9b0-13a5-49a8-b57b-b3f64e4316a72025-07-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDESlate Run Pharmaceuticals3a53668c-adda-44c2-a743-e79e467437e32025-04-01Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEFresenius Kabi USA, LLCd8d04647-8e25-4127-8ecf-360ce1991c2f2025-03-31Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEFresenius Kabi USA, LLC9772ab48-2ef1-4b9f-9a27-794f3e7e5c7a2025-03-06Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone hydrochlorideAMIODARONE HYDROCHLORIDEZydus Lifesciences Limited3e8db251-e3c5-4fba-be9a-6044a92f0beb2024-11-25Name fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsd42293e9-07fa-41b4-a08b-2e388f5b1e132024-08-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
NexteroneAMIODARONE HYDROCHLORIDEBaxter Healthcare Corporatione9108958-b8d7-4fba-87c3-9a32990de5512024-04-16Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.51772745-9ea9-42cd-97e6-7266f41ae3ca2024-04-11Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst7639dfe4-933c-2916-e053-2a91aa0a3fe72024-02-22Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
PaceroneAMIODARONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC02f4a736-63ed-4ad4-a1f1-b21a71e928bd2024-02-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst8d088060-70b5-e796-e053-2995a90a09692024-01-28Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEA-S Medication Solutionsbfd14110-4bf8-4fbe-a888-7b23fea6ffaa2024-01-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEA-S Medication Solutionsc536e0ad-2758-4022-8242-f5e9b6aca1e22023-08-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEMedical Purchasing Solutions, LLCd889c00c-e27e-4e27-e053-2995a90ad4e12023-06-01Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56054SUPPL2018-10-22
56007SUPPL2018-10-18
56006SUPPL2018-10-18
47978SUPPL2017-04-12
47918SUPPL2017-04-10
47917SUPPL2017-04-10
45988SUPPL2016-12-01
45955SUPPL2016-11-23
11399SUPPL2016-04-29
1175SUPPL2016-04-26
11397SUPPL2015-04-01
16154SUPPL2015-03-31
11398SUPPL2015-01-08
1174SUPPL2014-12-24
33677SUPPL2014-01-23
1173SUPPL2014-01-23
16153SUPPL2011-11-16
33676SUPPL2011-11-14
1172SUPPL2010-12-15
11396SUPPL2010-12-13
1171SUPPL2010-01-07
11395SUPPL2009-11-23
16152SUPPL2009-11-12
11394SUPPL2009-04-28
11393SUPPL2009-04-28
16151SUPPL2009-04-24
1170SUPPL2009-04-24
1169SUPPL2008-10-21
1168SUPPL2007-11-19
1167SUPPL2007-10-04
16150SUPPL2007-04-09
1166SUPPL2006-09-25
16149SUPPL2006-09-18
16148SUPPL2005-08-31
44026ORIG2005-07-29
40839SUPPL2005-04-27
16147SUPPL2004-12-06
11392SUPPL2004-12-06
16146SUPPL2004-11-08
1165SUPPL2004-09-03
40834ORIG2004-08-26
1163SUPPL2004-06-01
1164SUPPL2004-05-27
1162SUPPL2004-05-27
16145SUPPL2003-05-30
16144SUPPL2003-05-29
40838SUPPL1999-10-08
20174SUPPL1999-10-08
40836SUPPL1999-01-05
20172SUPPL1999-01-05
16143SUPPL1999-01-05
1161SUPPL1999-01-05
40837SUPPL1998-06-15
40835SUPPL1998-06-15
20173SUPPL1998-06-15