Home Applications 076362 Application 076362
Type ANDA
Sponsor TARO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE TABLET;ORAL 400MG No No 002 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE TABLET;ORAL 300MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076362-001 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL 2002-11-29 A076362-002 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02
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 · 84 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 2026-08-18 06:07:40 2026-07 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL 2002-11-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL 2002-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL 2002-11-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 bb7c543d1eb4…
Observed Orange Book normalized TE history# 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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 42291-139 Amiodarone Hydrochloride Amiodarone Hydrochloride AvKARE, Inc. ANDA Current 51672-4056 Amiodarone Hydrochloride Amiodarone Hydrochloride Taro Pharmaceuticals U.S.A., Inc. ANDA Current 51672-4056 Amiodarone Hydrochloride Amiodarone Hydrochloride Taro Pharmaceuticals U.S.A., Inc. ANDA Current 51672-4056 Amiodarone Hydrochloride Amiodarone Hydrochloride Taro Pharmaceuticals U.S.A., Inc. ANDA Current 51672-4056 Amiodarone Hydrochloride Amiodarone Hydrochloride Taro Pharmaceuticals U.S.A., Inc. ANDA Current 51672-4057 Amiodarone Hydrochloride Amiodarone Hydrochloride Taro Pharmaceuticals U.S.A., Inc. ANDA Current 51672-4057 Amiodarone Hydrochloride Amiodarone Hydrochloride Taro Pharmaceuticals U.S.A., Inc. ANDA Current 51672-4057 Amiodarone Hydrochloride Amiodarone Hydrochloride Taro Pharmaceuticals U.S.A., Inc. ANDA Current 51672-4057 Amiodarone Hydrochloride Amiodarone Hydrochloride Taro Pharmaceuticals U.S.A., Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 23821 ORIG 2005-07-28