Application 018185
- Type
- NDA
- Sponsor
- EGALET
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | INDOCIN SR | INDOMETHACIN | CAPSULE, EXTENDED RELEASE;ORAL | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018185-001 | INDOCIN SR | INDOMETHACIN | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N018185-001 | INDOCIN SR | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N018185-001 | INDOCIN SR | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N018185-001 | INDOCIN SR | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-02-23 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| Indomethacin | INDOMETHACIN | NuCare Pharmaceuticals, Inc. | 3e87e34a-6556-4b0f-e054-00144ff8d46c | 2024-08-13 | Boxed warning, Warnings, Adverse reactions | INDOMETHACIN |
| Indomethacin | INDOMETHACIN | NuCare Pharmaceuticals, Inc. | 3e8796a6-94c6-0db2-e054-00144ff88e88 | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | INDOMETHACIN |
| Indomethacin | INDOMETHACIN | Amneal Pharmaceuticals LLC | dbad7e61-2347-43b1-a422-9183e41c10ea | 2024-07-15 | Boxed warning, Warnings, Adverse reactions | INDOMETHACIN |
| Indomethacin | INDOMETHACIN | NuCare Pharmaceuticals, Inc. | 503455d9-471e-554f-e054-00144ff88e88 | 2024-07-09 | Boxed warning, Warnings, Adverse reactions | INDOMETHACIN |
| INDOMETHACIN | INDOMETHACIN | DIRECT RX | 4d9a253a-f014-4fab-e054-00144ff8d46c | 2024-04-02 | Boxed warning, Warnings, Adverse reactions | INDOMETHACIN |
| Indomethacin | INDOMETHACIN | Zydus Lifesciences Limited | c6ca86fb-df23-42c1-9d29-f15312faf60c | 2023-08-03 | INDOMETHACIN | |
| Indomethacin | INDOMETHACIN | Proficient Rx LP | ac458b4b-95bb-4235-a447-e8c4ba720257 | 2023-07-28 | Boxed warning, Warnings, Adverse reactions | INDOMETHACIN |
| Indomethacin | INDOMETHACIN | Fresenius Kabi USA, LLC | 30e38747-c553-4e2d-bc23-634e1dd90b8d | 2023-06-16 | Warnings, Adverse reactions | INDOMETHACIN |
| Indomethacin | INDOMETHACIN | Fresenius Kabi USA, LLC | dd5caa3f-3c09-4034-bf43-2df80c61c07b | 2023-06-01 | Warnings, Adverse reactions | INDOMETHACIN |
| Indomethacin | INDOMETHACIN | XLCare Pharmaceuticals Inc. | bc8a572d-e0e1-4d37-b3c4-b85415d50393 | 2023-01-16 | Boxed warning, Warnings, Adverse reactions | INDOMETHACIN |
| Indomethacin | INDOMETHACIN | Proficient Rx LP | 66e3205b-eab1-4864-bf36-116e9d79fe3e | 2023-01-01 | Boxed warning, Warnings, Adverse reactions | INDOMETHACIN |
| Indomethacin | INDOMETHACIN | Asclemed USA, Inc. | dfdcdb27-07a0-47e6-b8da-d9c99045a066 | 2022-10-12 | Boxed warning, Warnings, Adverse reactions | INDOMETHACIN |
| Indomethacin | INDOMETHACIN | Proficient Rx LP | 86c94559-b453-4e61-a76c-6962872f0655 | 2022-08-01 | Boxed warning, Warnings, Adverse reactions | INDOMETHACIN |
| Indomethacin | INDOMETHACIN | Proficient Rx LP | b094eb04-3177-431d-b5ac-edc4804750a2 | 2022-08-01 | Boxed warning, Warnings, Adverse reactions | INDOMETHACIN |
| Indomethacin | INDOMETHACIN | Asclemed USA, Inc. | 9c15102c-b6f9-4198-b592-152160591014 | 2022-07-25 | Boxed warning, Warnings, Adverse reactions | INDOMETHACIN |
| Indomethacin | INDOMETHACIN | Proficient Rx LP | 8aa48212-19b0-4304-9c61-dcf4db2b19ea | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | INDOMETHACIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80370 | SUPPL | 2024-11-25 |
| 80369 | SUPPL | 2024-11-25 |
| 80276 | SUPPL | 2024-11-22 |
| 67298 | SUPPL | 2021-04-30 |
| 67297 | SUPPL | 2021-04-30 |
| 67231 | SUPPL | 2021-04-29 |
| 58126 | SUPPL | 2019-03-28 |
| 58085 | SUPPL | 2019-03-27 |
| 58084 | SUPPL | 2019-03-27 |
| 23116 | SUPPL | 2016-05-18 |
| 14942 | SUPPL | 2016-05-11 |
| 11180 | SUPPL | 2016-05-11 |
| 11179 | SUPPL | 2016-05-11 |
| 870 | SUPPL | 2016-05-11 |