Application 073262
- Type
- ANDA
- Sponsor
- EPIC PHARMA LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SULINDAC | SULINDAC | TABLET;ORAL | 200MG | No | No |
| 002 | SULINDAC | SULINDAC | TABLET;ORAL | 150MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A073262-001 | SULINDAC | SULINDAC | 200MG | TABLET / ORAL | 1991-09-06 | ||
| A073262-002 | SULINDAC | SULINDAC | 150MG | TABLET / ORAL | 1991-09-06 |
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 | A073262-001 | SULINDAC | 200MG | TABLET / ORAL | 1991-09-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A073262-002 | SULINDAC | 150MG | TABLET / ORAL | 1991-09-06 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A073262-001 | SULINDAC | 200MG | TABLET / ORAL | 1991-09-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A073262-002 | SULINDAC | 150MG | TABLET / ORAL | 1991-09-06 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A073262-001 | SULINDAC | 200MG | TABLET / ORAL | 1991-09-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A073262-002 | SULINDAC | 150MG | TABLET / ORAL | 1991-09-06 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A073262-001 | SULINDAC | 200MG | TABLET / ORAL | 1991-09-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A073262-002 | SULINDAC | 150MG | TABLET / ORAL | 1991-09-06 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A073262-001 | SULINDAC | 200MG | TABLET / ORAL | 1991-09-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A073262-002 | SULINDAC | 150MG | TABLET / ORAL | 1991-09-06 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A073262-001 | SULINDAC | 200MG | TABLET / ORAL | 1991-09-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A073262-002 | SULINDAC | 150MG | TABLET / ORAL | 1991-09-06 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A073262-001 | SULINDAC | 200MG | TABLET / ORAL | 1991-09-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A073262-002 | SULINDAC | 150MG | TABLET / ORAL | 1991-09-06 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A073262-001 | SULINDAC | 200MG | TABLET / ORAL | 1991-09-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A073262-002 | SULINDAC | 150MG | TABLET / ORAL | 1991-09-06 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A073262-001 | SULINDAC | 200MG | TABLET / ORAL | 1991-09-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A073262-002 | SULINDAC | 150MG | TABLET / ORAL | 1991-09-06 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A073262-001 | SULINDAC | 200MG | TABLET / ORAL | 1991-09-06 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A073262-002 | SULINDAC | 150MG | TABLET / ORAL | 1991-09-06 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A073262-001 | SULINDAC | 200MG | TABLET / ORAL | 1991-09-06 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A073262-002 | SULINDAC | 150MG | TABLET / ORAL | 1991-09-06 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A073262-001 | SULINDAC | 200MG | TABLET / ORAL | 1991-09-06 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A073262-002 | SULINDAC | 150MG | TABLET / ORAL | 1991-09-06 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A073262-001 | SULINDAC | 200MG | TABLET / ORAL | 1991-09-06 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A073262-002 | SULINDAC | 150MG | TABLET / ORAL | 1991-09-06 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A073262-001 | SULINDAC | 200MG | TABLET / ORAL | 1991-09-06 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A073262-002 | SULINDAC | 150MG | TABLET / ORAL | 1991-09-06 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A073262-001 | SULINDAC | 200MG | TABLET / ORAL | 1991-09-06 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A073262-002 | SULINDAC | 150MG | TABLET / ORAL | 1991-09-06 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A073262-001 | SULINDAC | 200MG | TABLET / ORAL | 1991-09-06 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A073262-002 | SULINDAC | 150MG | TABLET / ORAL | 1991-09-06 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A073262-001 | SULINDAC | 200MG | TABLET / ORAL | 1991-09-06 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A073262-002 | SULINDAC | 150MG | TABLET / ORAL | 1991-09-06 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A073262-001 | SULINDAC | 200MG | TABLET / ORAL | 1991-09-06 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A073262-002 | SULINDAC | 150MG | TABLET / ORAL | 1991-09-06 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A073262-001 | SULINDAC | 200MG | TABLET / ORAL | 1991-09-06 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A073262-002 | SULINDAC | 150MG | TABLET / ORAL | 1991-09-06 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A073262-001 | SULINDAC | 200MG | TABLET / ORAL | 1991-09-06 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A073262-002 | SULINDAC | 150MG | TABLET / ORAL | 1991-09-06 | bb7c543d1eb4… |
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 |
|---|---|---|---|---|---|---|
| SULINDAC | SULINDAC | A-S Medication Solutions | 6041acc2-5e8a-4d3c-bf50-7e9447748e2b | 2026-05-08 | Boxed warning, Warnings, Adverse reactions | SULINDAC SULINDAC |
| SULINDAC | SULINDAC | A-S Medication Solutions | f4985b1b-7e2c-4911-897a-94c337794bab | 2026-03-19 | Boxed warning, Warnings, Adverse reactions | SULINDAC SULINDAC |
| SULINDAC | SULINDAC | PuraCap Laboratories LLC dba Blu Pharmaceuticals | 0feabf47-8d0d-48c0-b263-43db4969f39e | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | SULINDAC SULINDAC |
| SULINDAC | SULINDAC | PD-Rx Pharmaceuticals, Inc. | eb7acb87-6565-4524-a91a-02064ea8bd1a | 2025-10-23 | Boxed warning, Warnings, Adverse reactions | SULINDAC SULINDAC |
| SULINDAC | SULINDAC | PD-Rx Pharmaceuticals, Inc. | 1fffe88d-50c8-45cf-ac7c-a62b665c89a8 | 2025-04-04 | Boxed warning, Warnings, Adverse reactions | SULINDAC SULINDAC |
| Sulindac | SULINDAC | PD-Rx Pharmaceuticals, Inc. | 68d4eeed-2501-494b-b979-502720de86c0 | 2025-03-20 | Boxed warning, Warnings, Adverse reactions | Sulindac SULINDAC |
| SULINDAC | SULINDAC | Epic Pharma, LLC | 96c73bd2-4577-487d-a642-bd8f91e94c3a | 2024-12-20 | Boxed warning, Warnings, Adverse reactions | SULINDAC SULINDAC |
| SULINDAC | SULINDAC | Sun Pharmaceutical Industries, Inc. | a47e4259-d44b-4b7b-b517-841cb6840982 | 2024-10-23 | Boxed warning, Warnings, Adverse reactions | SULINDAC SULINDAC |
| Sulindac | SULINDAC | Actavis Pharma, Inc. | d8b9d517-5dd4-4c6b-8aa0-736bce87e7b4 | 2024-10-22 | Boxed warning, Warnings, Adverse reactions | Sulindac SULINDAC |
| SULINDAC | SULINDAC | Proficient Rx LP | d94e8865-d151-4fb1-bacd-f4e43819e3c2 | 2022-03-01 | Boxed warning, Warnings, Adverse reactions | SULINDAC SULINDAC |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 23155-005 | Sulindac | Sulindac | Heritage Pharmaceuticals Inc. | ANDA | Current |
| 23155-006 | Sulindac | Sulindac | Heritage Pharmaceuticals Inc. | ANDA | Current |
| 53808-0303 | Sulindac | SULINDAC | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0799 | Sulindac | SULINDAC | State of Florida DOH Central Pharmacy | ANDA | Current |