Application 075389
- Type
- ANDA
- Sponsor
- MAYNE PHARMA INC
Application Products#
| 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 | 100MG | No | No |
| 003 | AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | TABLET;ORAL | 400MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075389-001 | AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2001-01-25 | |
| A075389-002 | AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-12-28 | |
| A075389-003 | AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 400MG | TABLET / ORAL | AB | 2017-12-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075389-001 | AB |
| A075389-002 | AB |
| A075389-003 | AB |
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.
| 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 | A075389-001 | AMIODARONE HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2001-01-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075389-002 | AMIODARONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-12-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075389-003 | AMIODARONE HYDROCHLORIDE | 400MG | TABLET / ORAL | AB | 2017-12-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075389-001 | AMIODARONE HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2001-01-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075389-002 | AMIODARONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-12-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075389-003 | AMIODARONE HYDROCHLORIDE | 400MG | TABLET / ORAL | AB | 2017-12-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075389-001 | AMIODARONE HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2001-01-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075389-002 | AMIODARONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-12-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075389-003 | AMIODARONE HYDROCHLORIDE | 400MG | TABLET / ORAL | AB | 2017-12-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075389-001 | AMIODARONE HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2001-01-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075389-002 | AMIODARONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-12-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075389-003 | AMIODARONE HYDROCHLORIDE | 400MG | TABLET / ORAL | AB | 2017-12-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075389-001 | AMIODARONE HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2001-01-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075389-002 | AMIODARONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-12-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075389-003 | AMIODARONE HYDROCHLORIDE | 400MG | TABLET / ORAL | AB | 2017-12-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075389-001 | AMIODARONE HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2001-01-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075389-002 | AMIODARONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-12-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075389-003 | AMIODARONE HYDROCHLORIDE | 400MG | TABLET / ORAL | AB | 2017-12-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075389-001 | AMIODARONE HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2001-01-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075389-002 | AMIODARONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-12-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075389-003 | AMIODARONE HYDROCHLORIDE | 400MG | TABLET / ORAL | AB | 2017-12-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075389-001 | AMIODARONE HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2001-01-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075389-002 | AMIODARONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-12-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075389-003 | AMIODARONE HYDROCHLORIDE | 400MG | TABLET / ORAL | AB | 2017-12-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075389-001 | AMIODARONE HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2001-01-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075389-002 | AMIODARONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-12-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075389-003 | AMIODARONE HYDROCHLORIDE | 400MG | TABLET / ORAL | AB | 2017-12-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075389-001 | AMIODARONE HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2001-01-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075389-002 | AMIODARONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-12-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075389-003 | AMIODARONE HYDROCHLORIDE | 400MG | TABLET / ORAL | AB | 2017-12-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075389-001 | AMIODARONE HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2001-01-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075389-002 | AMIODARONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-12-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075389-003 | AMIODARONE HYDROCHLORIDE | 400MG | TABLET / ORAL | AB | 2017-12-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075389-001 | AMIODARONE HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2001-01-25 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075389-002 | AMIODARONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-12-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075389-003 | AMIODARONE HYDROCHLORIDE | 400MG | TABLET / ORAL | AB | 2017-12-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075389-001 | AMIODARONE HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2001-01-25 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075389-002 | AMIODARONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-12-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075389-003 | AMIODARONE HYDROCHLORIDE | 400MG | TABLET / ORAL | AB | 2017-12-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075389-001 | AMIODARONE HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2001-01-25 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A075389-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075389-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075389-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A075389-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075389-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075389-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075389-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075389-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075389-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075389-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075389-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075389-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075389-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075389-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075389-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075389-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075389-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075389-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075389-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075389-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075389-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075389-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075389-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075389-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075389-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075389-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075389-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075389-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075389-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075389-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075389-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075389-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075389-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075389-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075389-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075389-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075389-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075389-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075389-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075389-001 | AB | 1 | 1e350fbaab3a… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Amiodarone Hydrochloride | AMIODARONE HYDROCHLORIDE | Dr. Reddy's Labratories Inc. | 95cef33b-c0e6-b17c-7cbb-f5c066872705 | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | 075389 ANDA075389 |
| Amiodarone Hydrochloride | AMIODARONE HYDROCHLORIDE | AvPAK | 924c9359-ebc4-62a7-e053-2a95a90a4327 | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | 075389 ANDA075389 50268-097 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16714-843 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-843 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-843 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-843 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-843 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-844 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-844 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-844 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-844 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-844 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-845 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-845 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-845 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-845 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-845 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 50090-5062 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5062 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50268-097 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | AvPAK | ANDA | Current |
| 50268-097 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | AvPAK | ANDA | Current |
| 51862-240 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 51862-240 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 51862-240 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 51862-241 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 51862-241 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 51862-241 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 51862-242 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 51862-242 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 51862-242 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |