Application 077050
- Type
- ANDA
- Sponsor
- SUN PHARM INDS (IN)
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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077050-001 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | 2007-06-25 | ||
| A077050-002 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077050-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | 2007-06-25 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077050-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | 2007-06-25 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077050-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | 2007-06-25 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077050-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | 2007-06-25 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077050-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | 2007-06-25 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077050-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | 2007-06-25 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077050-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | 2007-06-25 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077050-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | 2007-06-25 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077050-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | 2007-06-25 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077050-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | 2007-06-25 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077050-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | 2007-06-25 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077050-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | 2007-06-25 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077050-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | 2007-06-25 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077050-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | 2007-06-25 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077050-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077050-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077050-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077050-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077050-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077050-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077050-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077050-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077050-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077050-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077050-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077050-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077050-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077050-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077050-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077050-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077050-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077050-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077050-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077050-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077050-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077050-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077050-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077050-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A077050-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A077050-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077050-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077050-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077050-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077050-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077050-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077050-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077050-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077050-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077050-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077050-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077050-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077050-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077050-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A077050-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077050-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077050-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077050-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A077050-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077050-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A077050-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A077050-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077050-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A077050-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A077050-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A077050-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A077050-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077050-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077050-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A077050-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A077050-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A077050-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A077050-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A077050-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A077050-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A077050-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A077050-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A077050-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077050-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A077050-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077050-002 | AB | 1 | ea99ee380514… |
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 | Sun Pharmaceutical Industries, Inc. | 92c758a3-e749-4a15-be4b-ee30b364b2b0 | 2025-06-12 | Warnings, Adverse reactions | 077050 ANDA077050 62756-130 62756-131 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 21695-834 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | Rebel Distributors Corp | ANDA | Current |
| 21695-835 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | Rebel Distributors Corp | ANDA | Current |
| 35356-679 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 50436-0131 | ondansetron hydrochloride | ondansetron hydrochloride | Unit Dose Services | ANDA | Current |
| 55045-3729 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | Dispensing Solutions, Inc. | ANDA | Current |
| 55045-3817 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | Dispensing Solutions, Inc. | ANDA | Current |
| 62756-130 | ondansetron hydrochloride | ondansetron hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-130 | ondansetron hydrochloride | ondansetron hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-130 | ondansetron hydrochloride | ondansetron hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-131 | ondansetron hydrochloride | ondansetron hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-131 | ondansetron hydrochloride | ondansetron hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-131 | ondansetron hydrochloride | ondansetron hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63629-4023 | ondansetron hydrochloride | ondansetron hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-4023 | ondansetron hydrochloride | ondansetron hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-4023 | ondansetron hydrochloride | ondansetron hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-4093 | ondansetron hydrochloride | ondansetron hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-4093 | ondansetron hydrochloride | ondansetron hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-4093 | ondansetron hydrochloride | ondansetron hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-6709 | ondansetron hydrochloride | ondansetron hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-6709 | ondansetron hydrochloride | ondansetron hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 66336-793 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | Dispensing Solutions, Inc. | ANDA | Current |