Home Applications 019281 Application 019281
Type NDA
Sponsor PHARMACIA AND UPJOHN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CYKLOKAPRON TRANEXAMIC ACID INJECTABLE;INJECTION 100MG/ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019281-001 CYKLOKAPRON TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019281-001 AP
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.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cyklokapron TRANEXAMIC ACID Pfizer Laboratories Div Pfizer Inc 6e89a7d9-4da4-42aa-b7f8-c602c24eefe5 2025-09-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019281 application number: NDA019281 ndc (product): 0013-1114
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0013-1114 Cyklokapron tranexamic acid Pfizer Laboratories Div Pfizer Inc NDA Current 0013-1114 Cyklokapron tranexamic acid Pharmacia and Upjohn Company LLC NDA Current 0013-1114 Cyklokapron tranexamic acid Pharmacia and Upjohn Company LLC NDA Current 0013-1114 Cyklokapron tranexamic acid Pharmacia and Upjohn Company LLC NDA Current 0013-1114 Cyklokapron tranexamic acid Pfizer Laboratories Div Pfizer Inc NDA Current 0013-1114 Cyklokapron tranexamic acid Pfizer Laboratories Div Pfizer Inc NDA Current 0013-1114 Cyklokapron tranexamic acid Pharmacia & Upjohn Company LLC NDA Current