Application 210441
- Type
- ANDA
- Sponsor
- APPCO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | TABLET;ORAL | 200MG | No | No |
| 002 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | TABLET;ORAL | 100MG | No | No |
| 003 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | TABLET;ORAL | 300MG | No | No |
| 004 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | TABLET;ORAL | 400MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210441-001 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-01 | |
| A210441-002 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | 100MG | TABLET / ORAL | AB | RS | 2022-09-19 |
| A210441-003 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | 300MG | TABLET / ORAL | AB | 2022-09-19 | |
| A210441-004 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | 400MG | TABLET / ORAL | AB | 2022-09-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210441-001 | AB |
| A210441-002 | AB |
| A210441-003 | AB |
| A210441-004 | 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 | A210441-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210441-002 | HYDROXYCHLOROQUINE SULFATE | 100MG | TABLET / ORAL | AB | RS | 2022-09-19 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210441-003 | HYDROXYCHLOROQUINE SULFATE | 300MG | TABLET / ORAL | AB | 2022-09-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210441-004 | HYDROXYCHLOROQUINE SULFATE | 400MG | TABLET / ORAL | AB | 2022-09-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210441-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210441-002 | HYDROXYCHLOROQUINE SULFATE | 100MG | TABLET / ORAL | AB | RS | 2022-09-19 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210441-003 | HYDROXYCHLOROQUINE SULFATE | 300MG | TABLET / ORAL | AB | 2022-09-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210441-004 | HYDROXYCHLOROQUINE SULFATE | 400MG | TABLET / ORAL | AB | 2022-09-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210441-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210441-002 | HYDROXYCHLOROQUINE SULFATE | 100MG | TABLET / ORAL | AB | RS | 2022-09-19 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210441-003 | HYDROXYCHLOROQUINE SULFATE | 300MG | TABLET / ORAL | AB | 2022-09-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210441-004 | HYDROXYCHLOROQUINE SULFATE | 400MG | TABLET / ORAL | AB | 2022-09-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210441-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210441-002 | HYDROXYCHLOROQUINE SULFATE | 100MG | TABLET / ORAL | AB | RS | 2022-09-19 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210441-003 | HYDROXYCHLOROQUINE SULFATE | 300MG | TABLET / ORAL | AB | 2022-09-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210441-004 | HYDROXYCHLOROQUINE SULFATE | 400MG | TABLET / ORAL | AB | 2022-09-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210441-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210441-002 | HYDROXYCHLOROQUINE SULFATE | 100MG | TABLET / ORAL | AB | RS | 2022-09-19 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210441-003 | HYDROXYCHLOROQUINE SULFATE | 300MG | TABLET / ORAL | AB | 2022-09-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210441-004 | HYDROXYCHLOROQUINE SULFATE | 400MG | TABLET / ORAL | AB | 2022-09-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210441-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210441-002 | HYDROXYCHLOROQUINE SULFATE | 100MG | TABLET / ORAL | AB | RS | 2022-09-19 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210441-003 | HYDROXYCHLOROQUINE SULFATE | 300MG | TABLET / ORAL | AB | 2022-09-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210441-004 | HYDROXYCHLOROQUINE SULFATE | 400MG | TABLET / ORAL | AB | 2022-09-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210441-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210441-002 | HYDROXYCHLOROQUINE SULFATE | 100MG | TABLET / ORAL | AB | RS | 2022-09-19 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210441-003 | HYDROXYCHLOROQUINE SULFATE | 300MG | TABLET / ORAL | AB | 2022-09-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210441-004 | HYDROXYCHLOROQUINE SULFATE | 400MG | TABLET / ORAL | AB | 2022-09-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210441-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210441-002 | HYDROXYCHLOROQUINE SULFATE | 100MG | TABLET / ORAL | AB | RS | 2022-09-19 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210441-003 | HYDROXYCHLOROQUINE SULFATE | 300MG | TABLET / ORAL | AB | 2022-09-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210441-004 | HYDROXYCHLOROQUINE SULFATE | 400MG | TABLET / ORAL | AB | 2022-09-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210441-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210441-002 | HYDROXYCHLOROQUINE SULFATE | 100MG | TABLET / ORAL | AB | RS | 2022-09-19 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210441-003 | HYDROXYCHLOROQUINE SULFATE | 300MG | TABLET / ORAL | AB | 2022-09-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210441-004 | HYDROXYCHLOROQUINE SULFATE | 400MG | TABLET / ORAL | AB | 2022-09-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210441-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210441-002 | HYDROXYCHLOROQUINE SULFATE | 100MG | TABLET / ORAL | AB | RS | 2022-09-19 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210441-003 | HYDROXYCHLOROQUINE SULFATE | 300MG | TABLET / ORAL | AB | 2022-09-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210441-004 | HYDROXYCHLOROQUINE SULFATE | 400MG | TABLET / ORAL | AB | 2022-09-19 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A210441-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210441-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210441-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210441-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A210441-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210441-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210441-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210441-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210441-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210441-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210441-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210441-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210441-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210441-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210441-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210441-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210441-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210441-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210441-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210441-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210441-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210441-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210441-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210441-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210441-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210441-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210441-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210441-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210441-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210441-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210441-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210441-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210441-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210441-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210441-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210441-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210441-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210441-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210441-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210441-004 | AB | 1 | d8e5a09893c0… |
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 |
|---|---|---|---|---|---|---|
| HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | Major Pharmaceuticals | ebe00e35-ed3d-40f4-9a93-a37b0da01ddb | 2026-07-27 | Warnings, Adverse reactions | 210441 ANDA210441 0904-7046 |
| HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | Cardinal Health 107, LLC | e5fe2ece-40a1-49eb-818f-62ff3c3bb199 | 2026-06-03 | Warnings, Adverse reactions | 210441 ANDA210441 55154-3567 |
| HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | AvPAK | a5b3455a-e842-7d4b-e053-2995a90adee3 | 2026-01-08 | Warnings, Adverse reactions | 210441 ANDA210441 50268-412 |
| HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | Dr. Reddy's Laboratories Inc. | 452092b4-7a8f-4d19-8113-f1c2a948d3d8 | 2025-12-05 | Warnings, Adverse reactions | 210441 ANDA210441 43598-131 43598-721 43598-133 43598-132 |
| HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | Bryant Ranch Prepack | 2c109188-d28b-4c65-8b52-819bd8547f2e | 2024-08-16 | Warnings, Adverse reactions | 210441 ANDA210441 |
| HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | Aphena Pharma Solutions - Tennessee, LLC | beff29fe-574f-4566-99ac-53ec3b3038a7 | 2023-05-01 | Warnings, Adverse reactions | 210441 ANDA210441 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0904-7046 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | Major Pharmaceuticals | ANDA | Current |
| 0904-7046 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | Major Pharmaceuticals | ANDA | Current |
| 0904-7046 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | Major Pharmaceuticals | ANDA | Current |
| 43598-131 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-131 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-132 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-132 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-133 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-133 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-721 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-721 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-721 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-721 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-721 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-721 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-721 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-721 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 50268-412 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | AvPAK | ANDA | Current |
| 50268-412 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | AvPAK | ANDA | Current |
| 55154-3567 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | Cardinal Health 107, LLC | ANDA | Current |