Application 207864
- Type
- ANDA
- Sponsor
- HYBIO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EPTIFIBATIDE | EPTIFIBATIDE | INJECTABLE;INJECTION | 2MG/ML | No | No |
| 002 | EPTIFIBATIDE | EPTIFIBATIDE | INJECTABLE;INJECTION | 75MG/100ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207864-001 | EPTIFIBATIDE | EPTIFIBATIDE | 2MG/ML | INJECTABLE / INJECTION | 2020-03-20 | ||
| A207864-002 | EPTIFIBATIDE | EPTIFIBATIDE | 75MG/100ML | INJECTABLE / INJECTION | 2020-03-20 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-03-09 01:35 UTC | 2022-03 | A207864-001 | EPTIFIBATIDE | 2MG/ML | INJECTABLE / INJECTION | 2020-03-20 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207864-002 | EPTIFIBATIDE | 75MG/100ML | INJECTABLE / INJECTION | 2020-03-20 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A207864-001 | EPTIFIBATIDE | 2MG/ML | INJECTABLE / INJECTION | 2020-03-20 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A207864-002 | EPTIFIBATIDE | 75MG/100ML | INJECTABLE / INJECTION | 2020-03-20 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207864-001 | EPTIFIBATIDE | 2MG/ML | INJECTABLE / INJECTION | 2020-03-20 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207864-002 | EPTIFIBATIDE | 75MG/100ML | INJECTABLE / INJECTION | 2020-03-20 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A207864-001 | EPTIFIBATIDE | 2MG/ML | INJECTABLE / INJECTION | 2020-03-20 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A207864-002 | EPTIFIBATIDE | 75MG/100ML | INJECTABLE / INJECTION | 2020-03-20 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A207864-001 | EPTIFIBATIDE | 2MG/ML | INJECTABLE / INJECTION | 2020-03-20 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A207864-002 | EPTIFIBATIDE | 75MG/100ML | INJECTABLE / INJECTION | 2020-03-20 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A207864-001 | EPTIFIBATIDE | 2MG/ML | INJECTABLE / INJECTION | 2020-03-20 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A207864-002 | EPTIFIBATIDE | 75MG/100ML | INJECTABLE / INJECTION | 2020-03-20 | c0c555d07b60… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207864-001 | EPTIFIBATIDE | 2MG/ML | INJECTABLE / INJECTION | 2020-03-20 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207864-002 | EPTIFIBATIDE | 75MG/100ML | INJECTABLE / INJECTION | 2020-03-20 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A207864-001 | EPTIFIBATIDE | 2MG/ML | INJECTABLE / INJECTION | 2020-03-20 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A207864-002 | EPTIFIBATIDE | 75MG/100ML | INJECTABLE / INJECTION | 2020-03-20 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A207864-001 | EPTIFIBATIDE | 2MG/ML | INJECTABLE / INJECTION | 2020-03-20 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A207864-002 | EPTIFIBATIDE | 75MG/100ML | INJECTABLE / INJECTION | 2020-03-20 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A207864-001 | EPTIFIBATIDE | 2MG/ML | INJECTABLE / INJECTION | 2020-03-20 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A207864-002 | EPTIFIBATIDE | 75MG/100ML | INJECTABLE / INJECTION | 2020-03-20 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A207864-001 | EPTIFIBATIDE | 2MG/ML | INJECTABLE / INJECTION | 2020-03-20 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A207864-002 | EPTIFIBATIDE | 75MG/100ML | INJECTABLE / INJECTION | 2020-03-20 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A207864-001 | EPTIFIBATIDE | 2MG/ML | INJECTABLE / INJECTION | 2020-03-20 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A207864-002 | EPTIFIBATIDE | 75MG/100ML | INJECTABLE / INJECTION | 2020-03-20 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A207864-001 | EPTIFIBATIDE | 2MG/ML | INJECTABLE / INJECTION | 2020-03-20 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A207864-002 | EPTIFIBATIDE | 75MG/100ML | INJECTABLE / INJECTION | 2020-03-20 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A207864-001 | EPTIFIBATIDE | 2MG/ML | INJECTABLE / INJECTION | 2020-03-20 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A207864-002 | EPTIFIBATIDE | 75MG/100ML | INJECTABLE / INJECTION | 2020-03-20 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A207864-001 | EPTIFIBATIDE | 2MG/ML | INJECTABLE / INJECTION | 2020-03-20 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A207864-002 | EPTIFIBATIDE | 75MG/100ML | INJECTABLE / INJECTION | 2020-03-20 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A207864-001 | EPTIFIBATIDE | 2MG/ML | INJECTABLE / INJECTION | 2020-03-20 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A207864-002 | EPTIFIBATIDE | 75MG/100ML | INJECTABLE / INJECTION | 2020-03-20 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A207864-001 | EPTIFIBATIDE | 2MG/ML | INJECTABLE / INJECTION | 2020-03-20 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A207864-002 | EPTIFIBATIDE | 75MG/100ML | INJECTABLE / INJECTION | 2020-03-20 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A207864-001 | EPTIFIBATIDE | 2MG/ML | INJECTABLE / INJECTION | 2020-03-20 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A207864-002 | EPTIFIBATIDE | 75MG/100ML | INJECTABLE / INJECTION | 2020-03-20 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A207864-001 | EPTIFIBATIDE | 2MG/ML | INJECTABLE / INJECTION | 2020-03-20 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A207864-002 | EPTIFIBATIDE | 75MG/100ML | INJECTABLE / INJECTION | 2020-03-20 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A207864-001 | EPTIFIBATIDE | 2MG/ML | INJECTABLE / INJECTION | 2020-03-20 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A207864-002 | EPTIFIBATIDE | 75MG/100ML | INJECTABLE / INJECTION | 2020-03-20 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Eptifibatide | EPTIFIBATIDE | Slate Run Pharmaceuticals, LLC | da421d88-6c00-428a-82a6-b3b4f7a68b85 | 2026-02-09 | Warnings, Adverse reactions | Eptifibatide EPTIFIBATIDE |
| Eptifibatide | EPTIFIBATIDE | Slate Run Pharmaceuticals, LLC | 2ab98ecd-c578-4032-a3d5-ae14d58d86a7 | 2026-02-09 | Warnings, Adverse reactions | Eptifibatide EPTIFIBATIDE |
| Eptifibatide | EPTIFIBATIDE | Hainan Shuangcheng Pharmaceuticals Co., Ltd. | c488f1af-a82c-4360-8886-79520635561a | 2025-10-20 | Warnings | Eptifibatide EPTIFIBATIDE |
| eptifibatide | EPTIFIBATIDE | Sagent Pharmaceuticals | a0d18778-0194-461a-a4ea-b2fca5df57c3 | 2024-08-15 | Warnings, Adverse reactions | eptifibatide EPTIFIBATIDE |
| Eptifibatide | EPTIFIBATIDE | Baxter Healthcare Company | 5f46b76b-5c83-49b9-ada8-4ad5cf81a38c | 2024-05-29 | Warnings, Adverse reactions | Eptifibatide EPTIFIBATIDE |
| Eptifibatide | EPTIFIBATIDE | Meitheal Pharmaceuticals Inc. | 3e7e7cd3-8efa-4d91-a5ab-7fd78b0cc65e | 2024-05-14 | Warnings, Adverse reactions | Eptifibatide EPTIFIBATIDE |
| Eptifibatide | EPTIFIBATIDE | Eugia US LLC | 00ad7bbe-cadd-4647-b74b-adfc9f2b5e94 | 2024-01-04 | Warnings, Adverse reactions | Eptifibatide EPTIFIBATIDE |
| Eptifibatide | EPTIFIBATIDE | Mylan Institutional LLC | a7a89c59-22fb-41fd-b70a-ac2395717db1 | 2021-05-28 | Warnings, Adverse reactions | Eptifibatide EPTIFIBATIDE |
| Eptifibatide | EPTIFIBATIDE | Mylan Institutional LLC | 88a37f9c-496b-4a6b-9665-4550abba04f1 | 2021-05-28 | Warnings, Adverse reactions | Eptifibatide EPTIFIBATIDE |
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 |
|---|---|---|---|---|---|
| 63739-911 | Eptifibatide | Eptifibatide Injection | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-923 | Eptifibatide | Eptifibatide Injection | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-970 | Eptifibatide | Eptifibatide Injection | McKesson Corporation dba SKY Packaging | ANDA | Current |