Application 019937
- Type
- NDA
- Sponsor
- ASTELLAS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | ADENOCARD | ADENOSINE | INJECTABLE;INJECTION | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019937-002 | ADENOCARD | ADENOSINE | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019937-002 | ADENOCARD | 3MG/ML | INJECTABLE / INJECTION | RLD | 1989-10-30 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019937-002 | ADENOCARD | 3MG/ML | INJECTABLE / INJECTION | RLD | 1989-10-30 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N019937-002 | ADENOCARD | 3MG/ML | INJECTABLE / INJECTION | RLD | 1989-10-30 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N019937-002 | ADENOCARD | 3MG/ML | INJECTABLE / INJECTION | RLD | 1989-10-30 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N019937-002 | ADENOCARD | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-10-30 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| adenosine | ADENOSINE | ProPharma Distribution | 48d72391-b3d4-bd97-e063-6294a90a9d6f | 2026-01-20 | Warnings, Adverse reactions | ADENOSINE |
| Adenosine | ADENOSINE | ProPharma Distribution | 364a4c53-0705-7969-e063-6294a90a1717 | 2025-12-17 | Warnings, Adverse reactions | ADENOSINE |
| Adenosine | ADENOSINE | REMEDYREPACK INC. | 9508caf5-0e3a-4d32-909d-bff7ea40ec30 | 2025-09-29 | Warnings, Adverse reactions | ADENOSINE |
| Adenosine | ADENOSINE | Meitheal Pharmaceuticals Inc. | b6851256-6cef-4f23-8129-19bb64380cd5 | 2025-04-14 | Warnings, Adverse reactions | ADENOSINE |
| Adenosine | ADENOSINE | NorthStar Rx LLC | 504b4b38-fb6c-4a59-b04f-73aa7b1cbfd9 | 2025-02-03 | Warnings, Adverse reactions | ADENOSINE |
| Adenosine | ADENOSINE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | df9bed83-6c82-4294-9442-5e7464c3aab1 | 2025-01-03 | Warnings, Adverse reactions | ADENOSINE |
| Adenosine | ADENOSINE | Medical Purchasing Solutions, LLC | 296af833-5724-3e23-e063-6394a90a6251 | 2024-12-16 | Warnings, Adverse reactions | ADENOSINE |
| adenosine | ADENOSINE | Sagent Pharmaceuticals | 5a55b45d-9cee-4c0c-9e44-021dbf70a018 | 2024-12-04 | Warnings, Adverse reactions | ADENOSINE |
| Tissen ICM 10 | ADENOSINE | Dalim Tissen | a2f648e2-0f8e-4635-9169-3185e8fbeb92 | 2024-11-25 | Warnings | ADENOSINE |
| Tissen NF 10 | ADENOSINE | Dalim Tissen | 0c71d3f0-949d-4c00-8758-4ae7c9fd11ed | 2024-11-25 | Warnings | ADENOSINE |
| ADENOSINE | ADENOSINE | HF Acquisition Co LLC, DBA HealthFirst | 1809fc7e-f5d8-18d8-e063-6394a90a7713 | 2024-05-09 | Warnings, Adverse reactions | ADENOSINE |
| ADENOSINE | ADENOSINE | HF Acquisition Co LLC, DBA HealthFirst | 996fc80e-b680-31f1-e053-2995a90aa0f1 | 2023-12-15 | Warnings, Adverse reactions | ADENOSINE |
| Adenosine | ADENOSINE | Eugia US LLC | 61d9b8f6-f93f-46ee-bec2-db8d46999792 | 2023-09-05 | Warnings, Adverse reactions | ADENOSINE |
| Reorganic Feminine wash | ADENOSINE | LAON COMMERCE co ltd | ffb36cf5-dbef-7638-e053-6394a90a5a95 | 2023-07-04 | Warnings | ADENOSINE |
| ADENOSINE | ADENOSINE | HF Acquisition Co LLC, DBA HealthFirst | fecdce1e-4233-f44c-e053-6294a90a714f | 2023-06-26 | Warnings, Adverse reactions | ADENOSINE |
| ReOrganic Womans Inner Care Essence Gel | ADENOSINE | LAON COMMERCE co ltd | fc7ec752-c676-93b8-e053-6294a90a4402 | 2023-05-25 | Warnings | ADENOSINE |
| adenosine | ADENOSINE | Medical Purchasing Solutions, LLC | a2a2fef9-d305-40ba-e053-2a95a90a0c54 | 2023-05-03 | Warnings, Adverse reactions | ADENOSINE |
| ADENOSINE | ADENOSINE | HF Acquisition Co LLC, DBA HealthFirst | fa6eb0f8-7c41-2e17-e053-6294a90ac8ca | 2023-04-28 | Warnings, Adverse reactions | ADENOSINE |
| Adenosine | ADENOSINE | Fresenius Kabi USA, LLC | e660f71c-35ed-438e-8505-4538f5e925a2 | 2023-04-01 | Warnings, Adverse reactions | ADENOSINE |
| Adenosine | ADENOSINE | Fresenius Kabi USA, LLC | f88a8cf7-d354-42f2-b5e8-ba002fcfc460 | 2023-03-02 | Warnings, Adverse reactions | ADENOSINE |