FDA.reportPublic FDA data

Application 020377

Type
NDA
Sponsor
WYETH PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CORDARONEAMIODARONE HYDROCHLORIDEINJECTABLE;INJECTION50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo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 1.

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
N020377-001CORDARONEAMIODARONE HYDROCHLORIDE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-03

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020377-001CORDARONE50MG/MLINJECTABLE / INJECTIONRLD1995-08-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020377-001CORDARONE50MG/MLINJECTABLE / INJECTIONRLD1995-08-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INJECTIONRLD1995-08-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INJECTIONRLD1995-08-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INJECTIONRLD1995-08-0387673890dc5c…
2021-03-12 10:30 UTC2021-03N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INJECTIONRLD1995-08-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INJECTIONRLD1995-08-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INJECTIONRLD1995-08-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INJECTIONRLD1995-08-033f01610625f2…
2019-09-15 20:21 UTC2019-09N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INJECTIONRLD1995-08-03b00525d2431f…
2019-07-19 19:46 UTC2019-07N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INJECTIONRLD1995-08-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-033f0d92c62455…
2023-05-13 08:27 UTC2023-05N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-03053a50430f4f…
2023-01-26 05:58 UTC2023-01N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-03e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020377-001CORDARONE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-08-03cb3db0bc1861…

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 3 · 49 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEREMEDYREPACK INC.4c149392-a4f0-4e2d-a13f-2b94810005de2026-08-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDERedpharm Drug57f7f2ea-4ca9-4ada-e063-6294a90a492b2026-08-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEREMEDYREPACK INC.51a88e8e-da02-4b97-9e7e-442fbffd908d2026-07-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
amiodarone hydrochlorideAMIODARONE HYDROCHLORIDESafecor Health LLCf49d011f-5ca6-4f75-ba16-2099fe42f5aa2026-06-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEBryant Ranch Prepackf3e631c5-1204-419c-8dbe-fa9b37a77f972026-06-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEBryant Ranch Prepackf4532f12-3b7a-42ab-9a6c-36fd2a3f192c2026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEMajor Pharmaceuticalsb8bf4aa2-abea-403d-a6d9-395caf5f87f02026-05-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEDr. Reddy's Labratories Inc.95cef33b-c0e6-b17c-7cbb-f5c0668727052026-04-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDECardinal Health 107, LLC0caedb97-56fd-4ec0-bfb2-c7683b8f5f1b2026-04-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEREMEDYREPACK INC.337c5695-e3f8-41c6-a088-a492d5c602152026-04-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDECardinal Health 107, LLC7bdc2236-3a1a-4210-a9fb-38f860227aa72026-04-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEMajor Pharmaceuticals352ed423-fc16-47bb-8e25-98e1c20f99912026-03-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDESun Pharmaceutical Industries, Inc.7ccd3733-c3af-4a11-8500-0f99194c14722026-03-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEAurobindo Pharma Limited7ae393d1-7469-432a-9f21-f5ebab1207d12026-02-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEREMEDYREPACK INC.e9151c1b-b70c-477b-868a-fffdc5c518302026-01-19Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEZhejiang Poly Pharm. Co., Ltd.0a28ae25-7cc4-4ac0-a2ba-7820fb93e25c2026-01-16Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEAvPAK924c9359-ebc4-62a7-e053-2a95a90a43272026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEBryant Ranch Prepack8377eb89-0d62-48c5-90e7-e96d545a46422025-12-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs28cd0224-3569-4308-bd40-480bc42305032025-12-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEProPharma Distribution364ab45e-b525-f310-e063-6394a90a44212025-12-17Warnings, Adverse reactionsName fallback
generic name: AMIODARONE HYDROCHLORIDE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
2421SUPPL2006-09-18
2420SUPPL2005-09-22
23579ORIG2005-07-29
24863SUPPL2004-11-08
2419SUPPL2004-11-08
2418SUPPL2004-11-08
2416SUPPL2004-11-08
24867SUPPL2004-09-03
41313SUPPL2003-08-08
20618SUPPL2003-08-08
24866SUPPL2003-05-30
24865SUPPL2003-05-30
24864SUPPL2003-05-30
2417SUPPL2003-05-30
24862SUPPL2001-07-11
2415SUPPL2001-07-11