Application 078539
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | TABLET;ORAL | EQ 4MG BASE | No | No |
| 002 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | TABLET;ORAL | EQ 8MG BASE | No | No |
| 003 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | TABLET;ORAL | EQ 24MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078539-001 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | |
| A078539-002 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-07-31 | |
| A078539-003 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET / ORAL | 2007-07-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078539-001 | AB |
| A078539-002 | 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 | A078539-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078539-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-07-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078539-003 | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET / ORAL | 2007-07-31 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078539-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078539-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-07-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078539-003 | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET / ORAL | 2007-07-31 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078539-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078539-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078539-003 | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET / ORAL | 2007-07-31 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078539-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078539-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078539-003 | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET / ORAL | 2007-07-31 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078539-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078539-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078539-003 | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET / ORAL | 2007-07-31 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078539-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078539-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078539-003 | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET / ORAL | 2007-07-31 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078539-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078539-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-07-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078539-003 | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET / ORAL | 2007-07-31 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078539-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078539-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-07-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078539-003 | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET / ORAL | 2007-07-31 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078539-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078539-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-07-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078539-003 | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET / ORAL | 2007-07-31 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078539-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078539-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-07-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078539-003 | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET / ORAL | 2007-07-31 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078539-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078539-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-07-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078539-003 | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET / ORAL | 2007-07-31 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078539-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078539-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-07-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078539-003 | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET / ORAL | 2007-07-31 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078539-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078539-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-07-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078539-003 | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET / ORAL | 2007-07-31 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078539-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A078539-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078539-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A078539-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078539-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078539-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078539-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078539-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078539-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078539-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078539-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078539-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078539-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078539-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078539-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078539-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078539-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078539-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078539-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078539-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078539-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078539-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078539-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078539-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078539-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078539-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078539-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078539-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078539-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078539-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078539-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078539-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A078539-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078539-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078539-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A078539-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078539-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A078539-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078539-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A078539-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078539-002 | AB | 1 | 74a2ff9319b5… |
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 Hydrochloride | ONDANSETRON HYDROCHLORIDE | REMEDYREPACK INC. | 960e2104-18c3-4cfa-abf6-f1b30c452918 | 2026-09-08 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron | ONDANSETRON | REMEDYREPACK INC. | 416be720-82e8-4a6d-8531-c1a29869daae | 2026-09-01 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Unit Dose Solutions, Inc. | 5566aebb-d84d-6d6a-e063-6294a90a746f | 2026-08-18 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 2a30d534-4607-4882-865e-56d2364acaad | 2026-08-07 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | 14276805-4e99-4bbe-ad76-ffc06eddb38a | 2026-08-06 | Warnings, Adverse reactions | 078539 ANDA078539 68788-9368 68788-9402 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 00b17a8e-9d38-a8d4-e063-6294a90a153e | 2026-08-05 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Proficient Rx LP | 0a14eb9a-0385-40e9-a7ec-71435450ac91 | 2026-08-01 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 57b0a1e5-5dfa-64a0-e063-6394a90acf36 | 2026-07-24 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Bryant Ranch Prepack | 3f2e8efe-7fd4-407c-a77b-bd6dd04608e2 | 2026-07-10 | Warnings, Adverse reactions | 078539 ANDA078539 71335-1596 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | REMEDYREPACK INC. | ee3e8cbe-4f0b-4361-a1b5-8329d85a2932 | 2026-07-08 | Warnings, Adverse reactions | 078539 ANDA078539 70518-1585 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Unit Dose Solutions, Inc. | 561dce26-92fa-e00b-e063-6294a90a1ab2 | 2026-07-08 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 58f16a00-3e66-29de-e053-2991aa0a59a0 | 2026-06-26 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | American Health Packaging | 9f015e60-1aec-4ae7-b28f-42f6c8f50455 | 2026-06-25 | Warnings, Adverse reactions | 078539 ANDA078539 68084-221 68084-220 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Coupler LLC | 546191d2-d092-6342-e063-6294a90a0cd3 | 2026-06-16 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Redpharm Drug | 541b9a0d-ae94-db6f-e063-6394a90a9805 | 2026-06-12 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Sportpharm LLC | c0be25a0-e13d-4242-93dc-0b86e82aadd7 | 2026-04-24 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | REMEDYREPACK INC. | 5cc67d95-6629-4451-9e34-2f7a60482be5 | 2026-04-10 | Warnings, Adverse reactions | 078539 ANDA078539 70518-3511 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Sportpharm LLC | b1324076-f83e-4816-9e02-6b2a689010bc | 2026-04-05 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron HCL | ONDANSETRON HCL | Advanced Rx of Tennessee, LLC | af735f22-6d6c-6e1f-e053-2a95a90a3532 | 2026-03-13 | Warnings, Adverse reactions | 078539 ANDA078539 80425-0074 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Bryant Ranch Prepack | e2c0e86c-e7fc-48f9-a894-02da8761001c | 2026-03-05 | Warnings, Adverse reactions | 078539 ANDA078539 |
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 |
|---|---|---|---|---|---|
| 68084-220 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-221 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-221 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-221 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-221 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-221 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | American Health Packaging | ANDA | Current |
| 68788-9368 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9368 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9368 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9368 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9402 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9402 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9402 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9402 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-1394 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1394 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1394 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1394 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1394 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1394 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1585 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1585 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1585 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1585 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1585 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1585 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-3511 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-3511 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70934-148 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-148 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-148 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-193 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceutical | ANDA | Current |
| 70934-193 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceutical | ANDA | Current |
| 70934-264 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-264 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-264 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-318 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-318 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-318 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71335-0205 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0205 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0205 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0205 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1357 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1357 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1596 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1596 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1612 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1855 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1855 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71610-119 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 72789-034 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-034 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-034 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-034 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-034 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 80425-0072 | Zofran | Ondansetron 4mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0072 | Zofran | Ondansetron 4mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0072 | Zofran | Ondansetron 4mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0072 | Zofran | Ondansetron 4mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0072 | Ondansetron HCL | Ondansetron HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0072 | Ondansetron HCL | Ondansetron HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0074 | Ondansetron HCL | Ondansetron HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0074 | Ondansetron HCL | Ondansetron HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0074 | Ondansetron HCL | Ondansetron HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0074 | Ondansetron HCL | Ondansetron HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0074 | Ondansetron HCL | Ondansetron HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0075 | Zofran | Ondansetron HCl 8mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0075 | Zofran | Ondansetron HCl 8mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0075 | Ondansetron HCL | Ondansetron HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0075 | Ondansetron HCL | Ondansetron HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |