Application 090469
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA
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 |
|---|---|---|---|---|---|---|---|
| A090469-001 | ONDANSETRON | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | |
| A090469-002 | ONDANSETRON | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090469-001 | AB |
| A090469-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-03-09 01:35 UTC | 2022-03 | A090469-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A090469-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A090469-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A090469-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090469-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090469-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A090469-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A090469-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A090469-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A090469-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A090469-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A090469-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A090469-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A090469-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A090469-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A090469-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A090469-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A090469-002 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090469-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090469-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A090469-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A090469-002 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A090469-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A090469-002 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090469-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090469-002 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090469-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090469-002 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090469-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090469-002 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090469-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090469-002 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A090469-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A090469-002 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A090469-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A090469-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090469-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090469-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A090469-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A090469-002 | AB | 1 | 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 |
|---|---|---|---|---|---|---|
| Ondansetron | ONDANSETRON | Asclemed USA, Inc. | 269c920c-643a-4eea-9bf9-b1f008915db9 | 2026-08-28 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | Preferred Pharmaceuticals, Inc. | 66ac9c17-bea7-4f8d-8a27-a1e0f9e65945 | 2026-08-07 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | Preferred Pharmaceuticals, Inc. | 70b48280-ef74-472b-abc3-128962bfcb05 | 2026-08-07 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | Sportpharm LLC | 3c4cda2f-13d9-42c5-b449-77deb06c8de5 | 2026-08-03 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | HAWAII REPACK, INC. | b76c5cc9-f1ca-428b-8989-36a66802b650 | 2026-07-17 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | REMEDYREPACK INC. | 18063a64-a4c0-4bad-911b-00df5c7bb65d | 2026-07-07 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | Bryant Ranch Prepack | 77397df5-5a4f-41b2-98bc-f817a1e497fc | 2026-07-02 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | Sportpharm LLC | 822404ad-af08-4c62-ae38-7d9819e86079 | 2026-07-01 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | St. Mary's Medical Park Pharmacy | 3207cf04-73b7-24ce-e054-00144ff8d46c | 2026-06-30 | Warnings, Adverse reactions | 090469 ANDA090469 |
| ONDANSETRON | ONDANSETRON | Direct Rx | b38feff2-900a-4e0c-8260-8f090edbc0bc | 2026-03-17 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | A-S Medication Solutions | 378d0963-d026-4478-8202-fbb636904a37 | 2026-02-18 | Warnings, Adverse reactions | 090469 ANDA090469 50090-1200 50090-1128 |
| Ondansetron | ONDANSETRON | NuCare Pharmaceuticals,Inc. | 9dff6676-e69e-779d-e053-2995a90a7c81 | 2026-01-27 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | NuCare Pharmaceuticals,Inc. | 76666e7e-3312-6f9d-e053-2991aa0af705 | 2026-01-23 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | Northwind Health Company, LLC | f2b502e2-03ed-fe5c-e053-2995a90a368e | 2026-01-01 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | Northwind Health Company, LLC | db9a0d22-9339-4319-e053-2a95a90a9592 | 2026-01-01 | Warnings, Adverse reactions | 090469 ANDA090469 51655-913 |
| Ondansetron | ONDANSETRON | Northwind Health Company, LLC | e07c38c0-e1c2-01de-e053-2995a90a390a | 2026-01-01 | Warnings, Adverse reactions | 090469 ANDA090469 51655-809 |
| Ondansetron | ONDANSETRON | PD-Rx Pharmaceuticals, Inc. | 9558d296-8edd-4aa1-875a-6247f9a8374d | 2025-09-15 | Warnings, Adverse reactions | 090469 ANDA090469 43063-857 |
| Ondansetron | ONDANSETRON | PD-Rx Pharmaceuticals, Inc. | 10afd68b-877f-4819-a314-39f2d56d5db9 | 2025-09-15 | Warnings, Adverse reactions | 090469 ANDA090469 43063-870 |
| Ondansetron | ONDANSETRON | Preferred Pharmaceuticals, Inc. | b9abd5ce-6aca-4fda-8f46-0bb5b7fdd5da | 2025-09-04 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | Cardinal Health 107, LLC | b50c1767-8a50-49ab-be31-6533021ae7c4 | 2025-08-21 | Warnings, Adverse reactions | 090469 ANDA090469 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16714-200 | Ondansetron | Ondansetron | NorthStar Rx LLC | ANDA | Current |
| 16714-200 | Ondansetron | Ondansetron | NorthStar Rx LLC | ANDA | Current |
| 16714-200 | Ondansetron | Ondansetron | NorthStar Rx LLC | ANDA | Current |
| 16714-200 | Ondansetron | Ondansetron | NorthStar Rx LLC | ANDA | Current |
| 16714-200 | Ondansetron | Ondansetron | NorthStar Rx LLC | ANDA | Current |
| 16714-201 | Ondansetron | Ondansetron | NorthStar Rx LLC | ANDA | Current |
| 16714-201 | Ondansetron | Ondansetron | NorthStar Rx LLC | ANDA | Current |
| 16714-201 | Ondansetron | Ondansetron | NorthStar Rx LLC | ANDA | Current |
| 16714-201 | Ondansetron | Ondansetron | NorthStar Rx LLC | ANDA | Current |
| 16714-201 | Ondansetron | Ondansetron | NorthStar Rx LLC | ANDA | Current |
| 33358-498 | Ondansetron | Ondansetron | RxChange Co. | ANDA | Current |
| 33358-512 | Ondansetron | Ondansetron | RxChange Co. | ANDA | Current |
| 43063-857 | Ondansetron | Ondansetron | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 43063-857 | Ondansetron | Ondansetron | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-857 | Ondansetron | Ondansetron | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-857 | Ondansetron | Ondansetron | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-857 | Ondansetron | Ondansetron | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-857 | Ondansetron | Ondansetron | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-857 | Ondansetron | Ondansetron | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-857 | Ondansetron | Ondansetron | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-857 | Ondansetron | Ondansetron | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-857 | Ondansetron | Ondansetron | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-857 | Ondansetron | Ondansetron | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-870 | Ondansetron | Ondansetron | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 43063-870 | Ondansetron | Ondansetron | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-870 | Ondansetron | Ondansetron | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-870 | Ondansetron | Ondansetron | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-870 | Ondansetron | Ondansetron | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-870 | Ondansetron | Ondansetron | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-870 | Ondansetron | Ondansetron | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-870 | Ondansetron | Ondansetron | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 45865-105 | Ondansetron | Ondansetron | Medsource Pharmaceuticals | ANDA | Current |
| 45865-563 | Ondansetron | Ondansetron | Medsource Pharmaceuticals | ANDA | Current |
| 45865-563 | Ondansetron | Ondansetron | Medsource Pharmaceuticals | ANDA | Current |
| 50090-1128 | Ondansetron | Ondansetron | A-S Medication Solutions | ANDA | Current |
| 50090-1128 | Ondansetron | Ondansetron | A-S Medication Solutions | ANDA | Current |
| 50090-1128 | Ondansetron | Ondansetron | A-S Medication Solutions | ANDA | Current |
| 50090-1128 | Ondansetron | Ondansetron | A-S Medication Solutions | ANDA | Current |
| 50090-1128 | Ondansetron | Ondansetron | A-S Medication Solutions | ANDA | Current |
| 50090-1200 | Ondansetron | Ondansetron | A-S Medication Solutions | ANDA | Current |
| 50090-1200 | Ondansetron | Ondansetron | A-S Medication Solutions | ANDA | Current |
| 50090-1200 | Ondansetron | Ondansetron | A-S Medication Solutions | ANDA | Current |
| 50090-1200 | Ondansetron | Ondansetron | A-S Medication Solutions | ANDA | Current |
| 50090-1200 | Ondansetron | Ondansetron | A-S Medication Solutions | ANDA | Current |
| 50090-1200 | Ondansetron | Ondansetron | A-S Medication Solutions | ANDA | Current |
| 50090-1200 | Ondansetron | Ondansetron | A-S Medication Solutions | ANDA | Current |
| 50090-1200 | Ondansetron | Ondansetron | A-S Medication Solutions | ANDA | Current |
| 50090-1201 | Ondansetron | Ondansetron | A-S Medication Solutions | ANDA | Current |
| 50090-1201 | Ondansetron | Ondansetron | A-S Medication Solutions | ANDA | Current |
| 50090-1201 | Ondansetron | Ondansetron | A-S Medication Solutions | ANDA | Current |
| 50090-4632 | Ondansetron | Ondansetron | A-S Medication Solutions | ANDA | Current |
| 50090-4632 | Ondansetron | Ondansetron | A-S Medication Solutions | ANDA | Current |
| 50436-0390 | Ondansetron | Ondansetron | Unit Dose Services | ANDA | Current |
| 51655-809 | Ondansetron | Ondansetron | Northwind Pharmaceuticals | ANDA | Current |
| 51655-913 | Ondansetron | Ondansetron | Northwind Pharmaceuticals | ANDA | Current |
| 51662-1246 | ONDANSETRON | ONDANSETRON | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1246 | ONDANSETRON | ONDANSETRON | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1246 | ONDANSETRON | ONDANSETRON | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1246 | ONDANSETRON | ONDANSETRON | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1514 | ONDANSETRON | ONDANSETRON | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1514 | ONDANSETRON | ONDANSETRON | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1514 | ONDANSETRON | ONDANSETRON | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 52959-425 | ONDANSETRON | ONDANSETRON | H. J. Harkins Company Inc. | ANDA | Current |
| 53002-0582 | Ondansetron | Ondansetron | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-0590 | Ondansetron | Ondansetron | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-0590 | Ondansetron | Ondansetron | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-0591 | Ondansetron | Ondansetron | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53217-382 | Ondansetron | Ondansetron | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 55700-672 | Ondansetron | Ondansetron | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-672 | Ondansetron | Ondansetron | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-672 | Ondansetron | Ondansetron | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-952 | Ondansetron | Ondansetron | Quality Care Products, LLC | ANDA | Current |
| 55700-952 | Ondansetron | Ondansetron | Quality Care Products, LLC | ANDA | Current |
| 57237-077 | Ondansetron | Ondansetron | Rising Health, LLC | ANDA | Current |
| 57237-077 | Ondansetron | Ondansetron | Rising Health, LLC | ANDA | Current |
| 57237-077 | Ondansetron | Ondansetron | Rising Health, LLC | ANDA | Current |
| 57237-077 | Ondansetron | Ondansetron | Rising Health, LLC | ANDA | Current |
| 57237-077 | Ondansetron | Ondansetron | Rising Health, LLC | ANDA | Current |
| 57237-078 | Ondansetron | Ondansetron | Rising Health, LLC | ANDA | Current |
| 57237-078 | Ondansetron | Ondansetron | Rising Health, LLC | ANDA | Current |