Application 077387
- Type
- ANDA
- Sponsor
- LUITPOLD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | ONDANSETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 2MG BASE/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | ONDANSETRON HYDROCHLORIDE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 2006-12-26 | cb3db0bc1861… |
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 | Preferred Pharmaceuticals, Inc. | 14276805-4e99-4bbe-ad76-ffc06eddb38a | 2026-08-06 | Warnings, Adverse reactions | ONDANSETRON HYDROCHLORIDE |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 57b0a1e5-5dfa-64a0-e063-6394a90acf36 | 2026-07-24 | Warnings, Adverse reactions | ONDANSETRON HYDROCHLORIDE |
| ondansetron | ONDANSETRON HYDROCHLORIDE | Ascend Laboratories, LLC | 2edc0788-dc38-4d21-ba8e-71f159e2d3b1 | 2026-07-22 | Warnings, Adverse reactions | ONDANSETRON HYDROCHLORIDE |
| ondansetron | ONDANSETRON HYDROCHLORIDE | Cardinal Health 107, LLC | cb02f2d7-31a9-4f12-880e-7ce7d85440d4 | 2026-07-17 | Warnings, Adverse reactions | ONDANSETRON HYDROCHLORIDE |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Bryant Ranch Prepack | 3f2e8efe-7fd4-407c-a77b-bd6dd04608e2 | 2026-07-10 | Warnings, Adverse reactions | ONDANSETRON HYDROCHLORIDE |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | REMEDYREPACK INC. | ee3e8cbe-4f0b-4361-a1b5-8329d85a2932 | 2026-07-08 | Warnings, Adverse reactions | ONDANSETRON HYDROCHLORIDE |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Unit Dose Solutions, Inc. | 561dce26-92fa-e00b-e063-6294a90a1ab2 | 2026-07-08 | Warnings, Adverse reactions | ONDANSETRON HYDROCHLORIDE |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Proficient Rx LP | 0a14eb9a-0385-40e9-a7ec-71435450ac91 | 2026-07-01 | Warnings, Adverse reactions | ONDANSETRON HYDROCHLORIDE |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Unit Dose Solutions, Inc. | 5566aebb-d84d-6d6a-e063-6294a90a746f | 2026-06-29 | Warnings, Adverse reactions | ONDANSETRON HYDROCHLORIDE |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 58f16a00-3e66-29de-e053-2991aa0a59a0 | 2026-06-26 | Warnings, Adverse reactions | ONDANSETRON HYDROCHLORIDE |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | American Health Packaging | 9f015e60-1aec-4ae7-b28f-42f6c8f50455 | 2026-06-25 | Warnings, Adverse reactions | ONDANSETRON HYDROCHLORIDE |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Coupler LLC | 546191d2-d092-6342-e063-6294a90a0cd3 | 2026-06-16 | Warnings, Adverse reactions | ONDANSETRON HYDROCHLORIDE |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 00b17a8e-9d38-a8d4-e063-6294a90a153e | 2026-06-15 | Warnings, Adverse reactions | ONDANSETRON HYDROCHLORIDE |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Redpharm Drug | 541b9a0d-ae94-db6f-e063-6394a90a9805 | 2026-06-12 | Warnings, Adverse reactions | ONDANSETRON HYDROCHLORIDE |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Sportpharm LLC | c0be25a0-e13d-4242-93dc-0b86e82aadd7 | 2026-04-24 | Warnings, Adverse reactions | ONDANSETRON HYDROCHLORIDE |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | REMEDYREPACK INC. | 5cc67d95-6629-4451-9e34-2f7a60482be5 | 2026-04-10 | Warnings, Adverse reactions | ONDANSETRON HYDROCHLORIDE |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Sportpharm LLC | b1324076-f83e-4816-9e02-6b2a689010bc | 2026-04-05 | Warnings, Adverse reactions | ONDANSETRON HYDROCHLORIDE |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Bryant Ranch Prepack | e2c0e86c-e7fc-48f9-a894-02da8761001c | 2026-03-05 | Warnings, Adverse reactions | ONDANSETRON HYDROCHLORIDE |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | A-S Medication Solutions | e0f69f57-aeb9-4890-85aa-e5976208e8be | 2026-02-12 | Warnings, Adverse reactions | ONDANSETRON HYDROCHLORIDE |
| ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | Cardinal Health 107, LLC | 30107d6f-5128-484f-b713-65244a98dc67 | 2026-01-14 | Warnings, Adverse reactions | ONDANSETRON HYDROCHLORIDE |