Home Applications 077610 Application 077610
Type ANDA
Sponsor WOCKHARDT Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077610-001 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077610-001 AP
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077610-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-10-30 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 3 of 3 · 49 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE Medical Purchasing Solutions, LLC 81a15062-ba1e-37c0-e053-2991aa0af945 2023-05-16 Warnings, Adverse reactions Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE Medical Purchasing Solutions, LLC 8969aad3-0219-e67f-e053-2995a90aac5a 2023-05-15 Warnings, Adverse reactions Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE Medical Purchasing Solutions, LLC 66700f8b-3f76-3749-e053-2a91aa0adfdb 2023-04-18 Warnings, Adverse reactions Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE amiodarone hydrochloride AMIODARONE HYDROCHLORIDE Zydus Pharmaceuticals USA Inc. b41cbcb5-9c5d-4e45-a4f2-952df5f22c00 2023-03-16 Boxed warning, Warnings, Adverse reactions Name fallback brand name: amiodarone hydrochloride generic name: AMIODARONE HYDROCHLORIDE Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE Unichem Pharmaceuticals (USA), Inc. a20d0c03-cfda-49d1-88c9-be1bf295bc6c 2023-02-23 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE Mylan Institutional LLC f0b3b743-9f62-4b02-ace5-c8d93637ecad 2022-03-15 Warnings, Adverse reactions Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE AuroMedics Pharma LLC 6cd870d7-6381-421a-89bc-bce5c9518219 2021-12-08 Warnings, Adverse reactions Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE Amiodarone hydrochloride AMIODARONE HYDROCHLORIDE Gland Pharma Limited 1f00c333-9667-4ebc-8849-009a3779c0c9 2021-08-26 Warnings, Adverse reactions Name fallback brand name: Amiodarone hydrochloride generic name: AMIODARONE HYDROCHLORIDE Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE Mylan Institutional LLC fcc8658c-761a-443f-8c32-1499d86028ec 2020-07-15 Warnings, Adverse reactions Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
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 NDC Name Nonproprietary name Labeler Marketing category Status 55648-739 Amiodarone Hydrochloride Amiodarone Hydrochloride Wockhardt Limited ANDA Current 64679-739 Amiodarone Hydrochloride Amiodarone Hydrochloride Wockhardt USA LLC. ANDA Current 64679-739 Amiodarone Hydrochloride Amiodarone Hydrochloride Wockhardt USA LLC. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 23877 ORIG 2008-11-25