Application 214458
- Type
- ANDA
- Sponsor
- TARO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMINOCAPROIC ACID | AMINOCAPROIC ACID | SOLUTION;ORAL | 0.25GM/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A214458-001 | AMINOCAPROIC ACID | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION / ORAL | 2023-03-24 |
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 | A214458-001 | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION / ORAL | 2023-03-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214458-001 | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION / ORAL | 2023-03-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214458-001 | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION / ORAL | AA | 2023-03-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214458-001 | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION / ORAL | AA | 2023-03-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214458-001 | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION / ORAL | AA | 2023-03-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214458-001 | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION / ORAL | AA | 2023-03-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214458-001 | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION / ORAL | AA | 2023-03-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214458-001 | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION / ORAL | AA | 2023-03-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214458-001 | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION / ORAL | AA | 2023-03-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A214458-001 | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION / ORAL | AA | 2023-03-24 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214458-001 | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION / ORAL | AA | 2023-03-24 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214458-001 | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION / ORAL | AA | 2023-03-24 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214458-001 | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION / ORAL | AA | 2023-03-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A214458-001 | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION / ORAL | AA | 2023-03-24 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A214458-001 | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION / ORAL | AA | 2023-03-24 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A214458-001 | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION / ORAL | AA | 2023-03-24 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A214458-001 | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION / ORAL | AA | 2023-03-24 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A214458-001 | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION / ORAL | AA | 2023-03-24 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A214458-001 | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION / ORAL | AA | 2023-03-24 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A214458-001 | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION / ORAL | AA | 2023-03-24 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A214458-001 | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION / ORAL | AA | 2023-03-24 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A214458-001 | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION / ORAL | AA | 2023-03-24 | 053a50430f4f… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214458-001 | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION / ORAL | 2023-03-24 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-08-23 18:47 UTC | 2025-08 | A214458-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214458-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214458-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214458-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214458-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214458-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214458-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A214458-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214458-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214458-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214458-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A214458-001 | AA | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A214458-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A214458-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A214458-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A214458-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A214458-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A214458-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A214458-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A214458-001 | AA | 1 | 053a50430f4f… |
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 |
|---|---|---|---|---|---|---|
| Aminocaproic acid | AMINOCAPROIC ACID | Amneal Pharmaceuticals LLC | 4a22e559-2dac-42d7-af8d-eb0ebbc2f76d | 2026-07-28 | Warnings, Adverse reactions | Aminocaproic acid AMINOCAPROIC ACID |
| AMINOCAPROIC ACID | AMINOCAPROIC ACID | Bryant Ranch Prepack | c2144bf8-1a26-4958-ba10-5358bd69cd23 | 2026-05-19 | Warnings, Adverse reactions | AMINOCAPROIC ACID AMINOCAPROIC ACID |
| Aminocaproic Acid | AMINOCAPROIC ACID | American Health Packaging | 4c2612ab-86a4-4c54-a5c0-e837f755965f | 2026-05-19 | Warnings, Adverse reactions | Aminocaproic Acid AMINOCAPROIC ACID |
| Aminocaproic Acid | AMINOCAPROIC ACID | Hospira, Inc. | 1c5bc1dd-e9ec-44c1-9281-67ad482315d9 | 2026-04-30 | Warnings, Adverse reactions | Aminocaproic Acid AMINOCAPROIC ACID |
| Aminocaproic acid | AMINOCAPROIC ACID | BPI LABS LLC | cfa601c4-b649-417e-a301-b246f080f1eb | 2026-01-05 | Warnings, Adverse reactions | Aminocaproic acid AMINOCAPROIC ACID |
| Aminocaproic Acid | AMINOCAPROIC ACID | Florida Pharmaceutical Products, LLC | 828568a7-1808-4330-b466-01889b2311a2 | 2025-12-20 | Warnings, Adverse reactions | Aminocaproic Acid AMINOCAPROIC ACID |
| Aminocaproic Acid | AMINOCAPROIC ACID | Medical Purchasing Solutions, LLC | 4629d585-134b-a479-e063-6294a90a3432 | 2025-12-17 | Warnings, Adverse reactions | Aminocaproic Acid AMINOCAPROIC ACID |
| AMINOCAPROIC ACID | AMINOCAPROIC ACID | Henry Schein, Inc. | 5ff09f58-c225-4792-9f1e-9d2b7a413521 | 2025-07-11 | Warnings, Adverse reactions | AMINOCAPROIC ACID AMINOCAPROIC ACID |
| Aminocaproic Acid | AMINOCAPROIC ACID | Apozeal Pharmaceuticals Inc. | 15aa2f36-ccc6-431a-99a2-45d812ef4bbf | 2025-06-14 | Warnings, Adverse reactions | Aminocaproic Acid AMINOCAPROIC ACID |
| Aminocaproic acid | AMINOCAPROIC ACID | Major Pharmaceuticals | 2612ee97-1723-40f2-99e6-3a736f63200f | 2025-03-28 | Warnings, Adverse reactions | Aminocaproic acid AMINOCAPROIC ACID |
| AMINOCAPROIC ACID | AMINOCAPROIC ACID | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 7d08ad63-71f5-4286-9622-84295668a293 | 2025-01-08 | Warnings, Adverse reactions | AMINOCAPROIC ACID AMINOCAPROIC ACID |
| Aminocaproic Acid | AMINOCAPROIC ACID | Vitruvias Therapeutics | d9f615a0-119c-4553-93a7-b30025b5fe14 | 2024-07-18 | Warnings, Adverse reactions | Aminocaproic Acid AMINOCAPROIC ACID |
| Aminocaproic Acid | AMINOCAPROIC ACID | Medical Purchasing Solutions, LLC | 15eadaf4-5801-8044-e063-6394a90a72cf | 2024-04-12 | Warnings, Adverse reactions | Aminocaproic Acid AMINOCAPROIC ACID |
| AMINOCAPROIC ACID | AMINOCAPROIC ACID | Carnegie Pharmaceuticals, LLC | 0d6560a3-c67e-428e-b9b8-fab538856b41 | 2024-03-05 | Warnings, Adverse reactions | AMINOCAPROIC ACID AMINOCAPROIC ACID |
| Aminocaproic Acid | AMINOCAPROIC ACID | Hikma Pharmaceuticals USA Inc. | 7b8f0ddb-00fd-4c22-afae-afe636f95f3a | 2024-01-08 | Warnings, Adverse reactions | Aminocaproic Acid AMINOCAPROIC ACID |
| Aminocaproic acid | AMINOCAPROIC ACID | Amneal Pharmaceuticals NY LLC | 65efb08a-c1ae-4bb7-a8a2-b7ae26485567 | 2023-11-01 | Warnings, Adverse reactions | Aminocaproic acid AMINOCAPROIC ACID |
| Aminocaproic acid | AMINOCAPROIC ACID | Novadoz Pharmaceuticals LLC | c5dc0c33-a0f9-43c4-9f10-3668f4361b87 | 2023-09-06 | Warnings, Adverse reactions | Aminocaproic acid AMINOCAPROIC ACID |
| Aminocaproic acid | AMINOCAPROIC ACID | Novadoz Pharmaceuticals LLC | 8a0d4fa5-8608-4e83-b5c7-d7e088d80281 | 2023-09-01 | Warnings, Adverse reactions | Aminocaproic acid AMINOCAPROIC ACID |
| AMINOCAPROIC ACID | AMINOCAPROIC ACID | Carnegie Pharmaceuticals, LLC | 871ec401-30f8-4154-a16e-b82dc1e04b49 | 2023-04-20 | Warnings, Adverse reactions | AMINOCAPROIC ACID AMINOCAPROIC ACID |
| Aminocaproic acid | AMINOCAPROIC ACID | TruPharma LLC | afffd309-3819-07c6-e053-2995a90a948b | 2022-11-17 | Warnings, Adverse reactions | Aminocaproic acid AMINOCAPROIC ACID |