Application 019280
- Type
- NDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CYKLOKAPRON | TRANEXAMIC ACID | TABLET;ORAL | 500MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019280-001 | CYKLOKAPRON | TRANEXAMIC ACID | 500MG | TABLET / ORAL | 1986-12-30 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019280-001 | CYKLOKAPRON | 500MG | TABLET / ORAL | 1986-12-30 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| Tranexamic Acid | TRANEXAMIC ACID | Mylan Institutional LLC | 6f033f1e-8c78-4c87-b870-6493944315ff | 2025-09-08 | Boxed warning, Warnings, Adverse reactions | TRANEXAMIC ACID |
| Cyklokapron | TRANEXAMIC ACID | Pfizer Laboratories Div Pfizer Inc | 6e89a7d9-4da4-42aa-b7f8-c602c24eefe5 | 2025-09-03 | Boxed warning, Warnings, Adverse reactions | Cyklokapron TRANEXAMIC ACID |
| tranexamic acid | TRANEXAMIC ACID | Provepharm Inc. | 1b8c3500-8e87-4b6e-b6a9-8da5f9c00820 | 2025-08-12 | Warnings, Adverse reactions | TRANEXAMIC ACID |
| TRANEXAMIC ACID | TRANEXAMIC ACID | Dr. Reddy's Laboratories Inc. | e5a52dad-e328-48f2-9182-4df46f5572ef | 2025-08-01 | Warnings, Adverse reactions | TRANEXAMIC ACID |
| Tranexamic Acid | TRANEXAMIC ACID | Actavis Pharma, Inc. | 3f07e93b-3568-487e-894f-8f90e5a0960a | 2025-07-15 | Warnings, Adverse reactions | TRANEXAMIC ACID |
| TRANEXAMIC ACID IN SODIUM CHLORIDE | TRANEXAMIC ACID | Amneal Pharmaceuticals Private Limited | 615a9bec-f769-4774-8b05-22473b93668c | 2025-05-30 | Warnings, Adverse reactions | TRANEXAMIC ACID |
| tranexamic acid in sodium chloride | TRANEXAMIC ACID | Avenacy Inc. | c3aad84a-aa99-42a0-b4b6-6fdee7585e19 | 2025-03-28 | Warnings, Adverse reactions | TRANEXAMIC ACID |
| TRANEXAMIC ACID | TRANEXAMIC ACID | Proficient Rx LP | 416cdb61-31fb-4554-835f-a7744aa33b61 | 2025-03-01 | Warnings, Adverse reactions | TRANEXAMIC ACID |
| Tranexamic Acid | TRANEXAMIC ACID | Nexus Pharmaceuticals LLC | c479dccd-15c6-47c2-9675-680ebb9db2cb | 2025-02-26 | Warnings, Adverse reactions | TRANEXAMIC ACID |
| Tranexamic Acid in Sodium Chloride | TRANEXAMIC ACID | HP Halden Pharma AS | 0c638812-ba60-49fe-a715-f40246b6cbf7 | 2025-01-14 | Warnings, Adverse reactions | TRANEXAMIC ACID |
| Tranexamic Acid | TRANEXAMIC ACID | Caplin Steriles Limited | 6326bdbf-fb2e-451a-a0a0-7d0b59ce5438 | 2025-01-03 | Warnings, Adverse reactions | TRANEXAMIC ACID |
| TRANEXAMIC ACID IN SODIUM CHLORIDE | TRANEXAMIC ACID | Fresenius Kabi USA, LLC | 63f6c65f-b06b-4905-8ff8-3ac87569c7e0 | 2024-11-15 | Warnings, Adverse reactions | TRANEXAMIC ACID |
| Tranexamic Acid | TRANEXAMIC ACID | Emcure Pharmaceuticals Limited | ceea739a-21dd-4c3a-9ef6-2b7ab2bdd95a | 2024-10-28 | TRANEXAMIC ACID | |
| Tranexamic Acid | TRANEXAMIC ACID | Sagent Pharmaceuticals | 80465b90-3f92-4e35-b2ba-69871bbd4a7f | 2024-08-14 | Warnings, Adverse reactions | TRANEXAMIC ACID |
| Tranexamic Acid | TRANEXAMIC ACID | Bryant Ranch Prepack | af95be04-a6ea-4789-8e79-7dcad332c640 | 2024-08-08 | Warnings, Adverse reactions | TRANEXAMIC ACID |
| TRANEXAMIC ACID IN SODIUM CHLORIDE | TRANEXAMIC ACID | Gland Pharma Limited | f06f07de-bedf-4b37-b15e-0959e0a154e6 | 2024-04-19 | Warnings, Adverse reactions | TRANEXAMIC ACID |
| tranexamic acid | TRANEXAMIC ACID | Avenacy, Inc. | 00630e54-0e84-465d-96a5-63486c87dcd9 | 2024-03-15 | Warnings, Adverse reactions | TRANEXAMIC ACID |
| Tranexamic Acid | TRANEXAMIC ACID | Armas Pharmaceuticals Inc. | a3468b9f-a1c1-43ca-afc0-5b32c8f58b83 | 2024-02-06 | Warnings, Adverse reactions | TRANEXAMIC ACID |
| TRANEXAMIC ACID | TRANEXAMIC ACID | HF Acquisition Co LLC, DBA HealthFirst | c53e2b38-6c49-acae-e053-2995a90ae9df | 2024-01-30 | Warnings, Adverse reactions | TRANEXAMIC ACID |
| Tranexamic Acid | TRANEXAMIC ACID | Bryant Ranch Prepack | 128c39ce-f625-47ec-9efe-4de696e5220f | 2024-01-15 | Warnings, Adverse reactions | TRANEXAMIC ACID |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.