Home Applications 077069 Application 077069
Type ANDA
Sponsor MURTY PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE TABLET;ORAL 200MG No No 002 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE TABLET;ORAL 400MG No No 003 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE TABLET;ORAL 100MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077069-001 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 A077069-002 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2005-04-08 A077069-003 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-10-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 · 126 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 A077069-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077069-002 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2005-04-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077069-003 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-10-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077069-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077069-002 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2005-04-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077069-003 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-10-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077069-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077069-002 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2005-04-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077069-003 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-10-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077069-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077069-002 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2005-04-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077069-003 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-10-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077069-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077069-002 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2005-04-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077069-003 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-10-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077069-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077069-002 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2005-04-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077069-003 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-10-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077069-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077069-002 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2005-04-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077069-003 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-10-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077069-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077069-002 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2005-04-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077069-003 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-10-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077069-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077069-002 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2005-04-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077069-003 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-10-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077069-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077069-002 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2005-04-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077069-003 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-10-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077069-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077069-002 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2005-04-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077069-003 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-10-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077069-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077069-002 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2005-04-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077069-003 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-10-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077069-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077069-002 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2005-04-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077069-003 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-10-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077069-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 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 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 31 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 42494-307 Amiodarone HCl Amiodarone Hydrochloride Cameron Pharmaceuticals, LLC ANDA Current 42494-307 Amiodarone HCl Amiodarone Hydrochloride Cameron Pharmaceuticals, LLC ANDA Current 42494-307 Amiodarone HCl Amiodarone Hydrochloride Cameron Pharmaceuticals, LLC ANDA Current 42494-307 Amiodarone HCl Amiodarone Hydrochloride Cameron Pharmaceuticals, LLC ANDA Current 42494-307 Amiodarone HCl Amiodarone Hydrochloride Cameron Pharmaceuticals, LLC ANDA Current 42494-307 Amiodarone HCl Amiodarone Hydrochloride Cameron Pharmaceuticals, LLC ANDA Current 42494-308 Amiodarone HCl Amiodarone Hydrochloride Cameron Pharmaceuticals, LLC ANDA Current 42494-308 Amiodarone HCl Amiodarone Hydrochloride Cameron Pharmaceuticals, LLC ANDA Current 42494-308 Amiodarone HCl Amiodarone Hydrochloride Cameron Pharmaceuticals, LLC ANDA Current 42494-308 Amiodarone HCl Amiodarone Hydrochloride Cameron Pharmaceuticals, LLC ANDA Current 42494-308 Amiodarone HCl Amiodarone Hydrochloride Cameron Pharmaceuticals, LLC ANDA Current 42494-308 Amiodarone HCl Amiodarone Hydrochloride Cameron Pharmaceuticals, LLC ANDA Current 42494-309 Amiodarone HCl Amiodarone Hydrochloride Cameron Pharmaceuticals, LLC ANDA Current 42494-309 Amiodarone HCl Amiodarone Hydrochloride Cameron Pharmaceuticals, LLC ANDA Current 42494-309 Amiodarone HCl Amiodarone Hydrochloride Cameron Pharmaceuticals, LLC ANDA Current 42494-309 Amiodarone HCl Amiodarone Hydrochloride Cameron Pharmaceuticals, LLC ANDA Current 42494-309 Amiodarone HCl Amiodarone Hydrochloride Cameron Pharmaceuticals, LLC ANDA Current 42494-309 Amiodarone HCl Amiodarone Hydrochloride Cameron Pharmaceuticals, LLC ANDA Current 51862-154 Amiodarone HCl Amiodarone Hydrochloride Mayne Pharma Inc. ANDA Current 51862-154 Amiodarone HCl Amiodarone Hydrochloride Mayne Pharma Inc. ANDA Current 51862-155 Amiodarone HCl Amiodarone Hydrochloride Mayne Pharma Inc. ANDA Current 51862-155 Amiodarone HCl Amiodarone Hydrochloride Mayne Pharma Inc. ANDA Current 51862-156 Amiodarone HCl Amiodarone Hydrochloride Mayne Pharma Inc. ANDA Current 51862-156 Amiodarone HCl Amiodarone Hydrochloride Mayne Pharma Inc. ANDA Current 63629-2001 Amiodarone HCl Amiodarone Hydrochloride Bryant Ranch Prepack ANDA Current 63629-2001 Amiodarone HCl Amiodarone Hydrochloride Bryant Ranch Prepack ANDA Current 63629-2001 Amiodarone HCl Amiodarone Hydrochloride Bryant Ranch Prepack ANDA Current 63629-2076 Amiodarone HCl Amiodarone Hydrochloride Bryant Ranch Prepack ANDA Current 63629-2076 Amiodarone HCl Amiodarone Hydrochloride Bryant Ranch Prepack ANDA Current 63629-2076 Amiodarone HCl Amiodarone Hydrochloride Bryant Ranch Prepack ANDA Current 63629-9294 Amiodarone HCl Amiodarone Hydrochloride Bryant Ranch Prepack ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 23855 ORIG 2005-07-28