Application 040104
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | TABLET;ORAL | 200MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040104-001 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040104-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A040104-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1995-11-30 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A040104-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040104-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040104-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040104-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040104-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040104-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040104-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040104-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040104-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040104-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040104-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040104-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040104-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040104-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040104-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040104-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040104-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A040104-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A040104-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A040104-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040104-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A040104-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A040104-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A040104-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A040104-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A040104-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A040104-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040104-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A040104-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A040104-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040104-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040104-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040104-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040104-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A040104-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A040104-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040104-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A040104-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A040104-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A040104-001 | AB | 1 | cb3db0bc1861… |
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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-8218 | Hydroxychloroquine Sulfate | Hydroxychloroquine Sulfate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8218 | Hydroxychloroquine Sulfate | Hydroxychloroquine Sulfate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0781-1407 | Hydroxychloroquine Sulfate | Hydroxychloroquine Sulfate | Sandoz Inc | ANDA | Current |
| 0781-5994 | Hydroxychloroquine Sulfate | Hydroxychloroquine Sulfate | Sandoz Inc | ANDA | Current |
| 0781-5994 | Hydroxychloroquine Sulfate | Hydroxychloroquine Sulfate | Sandoz Inc | ANDA | Current |
| 0781-5994 | Hydroxychloroquine Sulfate | Hydroxychloroquine Sulfate | Sandoz Inc | ANDA | Current |
| 0781-5994 | Hydroxychloroquine Sulfate | Hydroxychloroquine Sulfate | Sandoz Inc | ANDA | Current |
| 0781-5994 | Hydroxychloroquine Sulfate | Hydroxychloroquine Sulfate | Sandoz Inc | ANDA | Current |
| 0781-5994 | Hydroxychloroquine Sulfate | Hydroxychloroquine Sulfate | Sandoz Inc | ANDA | Current |
| 0781-5994 | Hydroxychloroquine Sulfate | Hydroxychloroquine Sulfate | Sandoz Inc | ANDA | Current |
| 0904-6508 | Hydroxychloroquine Sulfate | Hydroxychloroquine Sulfate | Major Pharmaceuticals | ANDA | Current |
| 0904-6884 | Hydroxychloroquine Sulfate | Hydroxychloroquine Sulfate | Major Pharmaceuticals | ANDA | Current |
| 0904-6884 | Hydroxychloroquine Sulfate | Hydroxychloroquine Sulfate | Major Pharmaceuticals | ANDA | Current |
| 0904-6884 | Hydroxychloroquine Sulfate | Hydroxychloroquine Sulfate | Major Pharmaceuticals | ANDA | Current |
| 16714-474 | Hydroxychloroquine Sulfate | Hydroxychloroquine Sulfate | Northstar RxLLC | ANDA | Current |
| 16714-753 | Hydroxychloroquine Sulfate | Hydroxychloroquine Sulfate | Northstar RxLLC | ANDA | Current |
| 16714-753 | Hydroxychloroquine Sulfate | Hydroxychloroquine Sulfate | Northstar RxLLC | ANDA | Current |
| 16714-753 | Hydroxychloroquine Sulfate | Hydroxychloroquine Sulfate | Northstar RxLLC | ANDA | Current |
| 16714-753 | Hydroxychloroquine Sulfate | Hydroxychloroquine Sulfate | Northstar RxLLC | ANDA | Current |
| 16714-753 | Hydroxychloroquine Sulfate | Hydroxychloroquine Sulfate | Northstar RxLLC | ANDA | Current |
| 43353-103 | Hydroxychloroquine Sulfate | Hydroxychloroquine Sulfate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 67296-1780 | Hydroxychloroquine Sulfate | Hydroxychloroquine Sulfate | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1780 | Hydroxychloroquine Sulfate | Hydroxychloroquine Sulfate | RedPharm Drug, Inc. | ANDA | Current |
| 71610-047 | Hydroxychloroquine Sulfate | Hydroxychloroquine Sulfate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-047 | Hydroxychloroquine Sulfate | Hydroxychloroquine Sulfate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |