Application 077717
- Type
- ANDA
- Sponsor
- NESHER PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ONDANSETRON | ONDANSETRON | TABLET, ORALLY DISINTEGRATING;ORAL | 4MG | No | No |
| 002 | ONDANSETRON | ONDANSETRON | TABLET, ORALLY DISINTEGRATING;ORAL | 8MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077717-001 | ONDANSETRON | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | ||
| A077717-002 | ONDANSETRON | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 |
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 | A077717-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077717-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077717-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077717-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077717-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077717-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077717-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077717-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077717-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077717-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077717-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077717-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077717-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077717-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077717-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077717-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077717-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077717-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077717-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077717-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077717-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077717-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077717-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077717-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077717-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077717-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077717-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077717-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077717-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077717-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077717-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077717-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077717-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077717-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077717-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077717-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077717-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077717-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077717-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077717-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2007-06-25 | 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 |
|---|---|---|---|---|---|---|
| Ondansetron | ONDANSETRON | REMEDYREPACK INC. | c0d827d0-333f-4187-ac75-9dc7d34b6169 | 2026-08-11 | Warnings, Adverse reactions | Ondansetron ONDANSETRON |
| Ondansetron | ONDANSETRON | Preferred Pharmaceuticals, Inc. | 66ac9c17-bea7-4f8d-8a27-a1e0f9e65945 | 2026-08-07 | Warnings, Adverse reactions | Ondansetron ONDANSETRON |
| Ondansetron | ONDANSETRON | Preferred Pharmaceuticals Inc. | 7975d78c-9bb6-467a-9c2d-ea15bde7af5c | 2026-08-07 | Warnings, Adverse reactions | Ondansetron ONDANSETRON |
| Ondansetron | ONDANSETRON | Preferred Pharmaceuticals, Inc. | 70b48280-ef74-472b-abc3-128962bfcb05 | 2026-08-07 | Warnings, Adverse reactions | Ondansetron ONDANSETRON |
| Ondansetron | ONDANSETRON | Sportpharm LLC | 3c4cda2f-13d9-42c5-b449-77deb06c8de5 | 2026-08-03 | Warnings, Adverse reactions | Ondansetron ONDANSETRON |
| Ondansetron | ONDANSETRON | A-S Medication Solutions | 5a81a39b-051b-414e-a6b0-d844de4e9ab4 | 2026-07-29 | Warnings, Adverse reactions | Ondansetron ONDANSETRON |
| Ondansetron | ONDANSETRON | A-S Medication Solutions | 02ddd5f5-76d3-4f1c-9af3-d39e05a19c29 | 2026-07-29 | Warnings, Adverse reactions | Ondansetron ONDANSETRON |
| Ondansetron | ONDANSETRON | St. Mary's Medical Park Pharmacy | 41366a20-0727-0446-e063-6294a90a957f | 2026-07-28 | Warnings, Adverse reactions | Ondansetron ONDANSETRON |
| ONDANSETRON | ONDANSETRON | Henry Schein, Inc. | 1a44601b-c31c-4779-a688-28cc4cc75e8b | 2026-07-23 | Warnings, Adverse reactions | ONDANSETRON ONDANSETRON |
| ondansetron | ONDANSETRON HYDROCHLORIDE | Ascend Laboratories, LLC | 2edc0788-dc38-4d21-ba8e-71f159e2d3b1 | 2026-07-22 | Warnings, Adverse reactions | ondansetron |
| ondansetron | ONDANSETRON HYDROCHLORIDE | Cardinal Health 107, LLC | cb02f2d7-31a9-4f12-880e-7ce7d85440d4 | 2026-07-17 | Warnings, Adverse reactions | ondansetron |
| Ondansetron | ONDANSETRON | HAWAII REPACK, INC. | b76c5cc9-f1ca-428b-8989-36a66802b650 | 2026-07-17 | Warnings, Adverse reactions | Ondansetron ONDANSETRON |
| Ondansetron | ONDANSETRON | REMEDYREPACK INC. | 18063a64-a4c0-4bad-911b-00df5c7bb65d | 2026-07-07 | Warnings, Adverse reactions | Ondansetron ONDANSETRON |
| Ondansetron | ONDANSETRON | REMEDYREPACK INC. | 9c3ad9c1-474e-4331-a017-09cec46702d8 | 2026-07-07 | Warnings, Adverse reactions | Ondansetron ONDANSETRON |
| Ondansetron | ONDANSETRON | Bryant Ranch Prepack | 77397df5-5a4f-41b2-98bc-f817a1e497fc | 2026-07-02 | Warnings, Adverse reactions | Ondansetron ONDANSETRON |
| ONDANSETRON | ONDANSETRON | Sportpharm LLC | de72f1ec-75dd-4659-a1a0-32b28b72c799 | 2026-07-02 | Warnings, Adverse reactions | ONDANSETRON ONDANSETRON |
| Ondansetron | ONDANSETRON | Sportpharm LLC | 822404ad-af08-4c62-ae38-7d9819e86079 | 2026-07-01 | Warnings, Adverse reactions | Ondansetron ONDANSETRON |
| Ondansetron | ONDANSETRON | St. Mary's Medical Park Pharmacy | 3207cf04-73b7-24ce-e054-00144ff8d46c | 2026-06-30 | Warnings, Adverse reactions | Ondansetron ONDANSETRON |
| Ondansetron | ONDANSETRON | NuCare Pharmaceuticals,Inc | 4575d288-be0c-f6c3-e063-6294a90af708 | 2026-06-29 | Warnings, Adverse reactions | Ondansetron ONDANSETRON |
| Ondansetron | ONDANSETRON | Cardinal Health 107, LLC | 1b9c2d9f-62a8-4d26-a041-a598bc59e300 | 2026-06-26 | Warnings, Adverse reactions | Ondansetron ONDANSETRON |