Home Applications 202436 Application 202436
Type ANDA
Sponsor ACIC PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TRANEXAMIC ACID TRANEXAMIC ACID INJECTABLE;INJECTION 100MG/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A202436-001 TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202436-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202436-001 TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP 2014-02-11 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 Tranexamic Acid TRANEXAMIC ACID Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 4f42a81c-37e3-4b57-8e9a-d42c55bbfc52 2026-05-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202436 application number: ANDA202436
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 16 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 42192-605 Tranexamic Acid Tranexamic Acid Acella Pharmaceuticals ANDA Current 67850-041 Tranexamic Acid Tranexamic Acid Methapharm, Inc. ANDA Current 67850-041 Tranexamic Acid Tranexamic Acid Methapharm, Inc. ANDA Current 67850-041 Tranexamic Acid Tranexamic Acid Methapharm, Inc. ANDA Current 67850-041 Tranexamic Acid Tranexamic Acid Methapharm Inc. ANDA Current 67850-041 Tranexamic Acid Tranexamic Acid Methapharm, Inc. ANDA Current 67850-041 Tranexamic Acid Tranexamic Acid Methapharm, Inc. ANDA Current 67850-041 Tranexamic Acid Tranexamic Acid Methapharm, Inc. ANDA Current 67850-042 Tranexamic Acid Tranexamic Acid Methapharm, Inc. ANDA Current 67850-042 Tranexamic Acid Tranexamic acid Methapharm, Inc. ANDA Current 67850-042 Tranexamic Acid Tranexamic Acid Methapharm, Inc. ANDA Current 67850-042 Tranexamic Acid Tranexamic Acid Methapharm, Inc. ANDA Current 67850-042 Tranexamic Acid Tranexamic Acid Methapharm, Inc. ANDA Current 67850-042 Tranexamic Acid Tranexamic Acid Methapharm, Inc. ANDA Current 67850-042 Tranexamic Acid Tranexamic Acid Methapharm, Inc. ANDA Current 67850-042 Tranexamic Acid Tranexamic Acid Methapharm, Inc. ANDA Current