Application 214428
- Type
- ANDA
- Sponsor
- BEIJING
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NIACIN | NIACIN | TABLET, EXTENDED RELEASE;ORAL | 500MG | No | No |
| 002 | NIACIN | NIACIN | TABLET, EXTENDED RELEASE;ORAL | 1GM | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A214428-001 | NIACIN | NIACIN | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 | ||
| A214428-002 | NIACIN | NIACIN | 1GM | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-03-09 01:35 UTC | 2022-03 | A214428-001 | NIACIN | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-11-22 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A214428-002 | NIACIN | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-11-22 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A214428-001 | NIACIN | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-11-22 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A214428-002 | NIACIN | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-11-22 | 782e0a99824c… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A214428-001 | NIACIN | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A214428-002 | NIACIN | 1GM | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A214428-001 | NIACIN | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A214428-002 | NIACIN | 1GM | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A214428-001 | NIACIN | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A214428-002 | NIACIN | 1GM | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A214428-001 | NIACIN | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A214428-002 | NIACIN | 1GM | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A214428-001 | NIACIN | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A214428-002 | NIACIN | 1GM | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A214428-001 | NIACIN | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A214428-002 | NIACIN | 1GM | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A214428-001 | NIACIN | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A214428-002 | NIACIN | 1GM | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A214428-001 | NIACIN | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A214428-002 | NIACIN | 1GM | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A214428-001 | NIACIN | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A214428-002 | NIACIN | 1GM | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A214428-001 | NIACIN | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A214428-002 | NIACIN | 1GM | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A214428-001 | NIACIN | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A214428-002 | NIACIN | 1GM | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A214428-001 | NIACIN | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A214428-002 | NIACIN | 1GM | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A214428-001 | NIACIN | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A214428-002 | NIACIN | 1GM | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214428-001 | NIACIN | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214428-002 | NIACIN | 1GM | TABLET, EXTENDED RELEASE / ORAL | 2021-11-22 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-04-08 23:34 UTC | 2022-04 | A214428-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A214428-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A214428-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A214428-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A214428-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A214428-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A214428-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A214428-002 | AB | 1 | 782e0a99824c… |
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 |
|---|---|---|---|---|---|---|
| Niacin | NIACIN | Golden State Medical Supply, Inc. | 8eff9205-84ac-e69d-e053-2995a90aad4b | 2026-04-15 | Warnings, Adverse reactions | Niacin NIACIN |
| Niacin | NIACIN | AvPAK | dd60fe81-3d54-4a29-9502-601be89c575e | 2026-02-25 | Warnings, Adverse reactions | Niacin NIACIN |
| Niacin | NIACIN | QUAGEN PHARMACEUTICALS LLC | 249e27ac-e1e7-42dc-84f6-cd32fd1d9dee | 2025-12-25 | Warnings, Adverse reactions | Niacin NIACIN |
| Niacin | NIACIN | Redmont Pharmaceuticals, LLC | f51f7e6d-b132-48d8-8bb1-54203472f0d8 | 2025-12-17 | Warnings, Adverse reactions | Niacin NIACIN |
| NIACIN | NIACIN | Chartwell RX, LLC | 568c3a99-b6e8-48b4-bb68-867bbcefa027 | 2025-12-08 | Warnings, Adverse reactions | NIACIN NIACIN |
| Niacin | NIACIN | Lannett Company, Inc. | d7b66e13-00ed-48a9-a54a-8e474cc31d54 | 2025-11-10 | Warnings, Adverse reactions | Niacin NIACIN |
| Niacin | NIACIN | Amneal Pharmaceuticals LLC | 7250313b-b2ef-4736-bd25-2f29c2ac0eb9 | 2025-10-03 | Warnings, Adverse reactions | Niacin NIACIN |
| Niacin | NIACIN | Macleods Pharmaceuticals Limited | 52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e | 2025-01-10 | Warnings, Adverse reactions | Niacin NIACIN |
| NIACIN | NIACIN | Sun Pharmaceutical Industries, Inc. | 8e290f96-e8c6-47fd-863f-1c9480f28d9b | 2023-11-24 | Warnings, Adverse reactions | NIACIN NIACIN |
| NIACIN | NIACIN | Lupin Pharmaceuticals, Inc. | 92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9 | 2023-10-06 | Warnings, Adverse reactions | NIACIN NIACIN |
| Niacin | NIACIN | Aurobindo Pharma Limited | 43233a21-3f90-4c69-bbeb-f50d5f2d35ae | 2023-02-14 | Warnings, Adverse reactions | Niacin NIACIN |
| Niacor | NIACIN | Avondale Pharmaceuticals, LLC | bf287412-160b-403f-8eb4-57f29a475902 | 2021-12-23 | Warnings, Adverse reactions | NIACIN |
| Niacin | NIACIN | Emerald Therapeutics, LLC | 5fceeb58-e54d-43c1-8abb-33feea69d663 | 2021-04-07 | Warnings, Adverse reactions | Niacin NIACIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.