Application 087907
- Type
- ANDA
- Sponsor
- ARMSTRONG PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EPINEPHRINE | EPINEPHRINE | AEROSOL, METERED;INHALATION | 0.2MG/INH | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A087907-001 | EPINEPHRINE | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 |
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 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A087907-001 | EPINEPHRINE | 0.2MG/INH | AEROSOL, METERED / INHALATION | 1984-05-23 | 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 |
|---|---|---|---|---|---|---|
| EPINEPHRINE | EPINEPHRINE | HF Acquisition Co LLC, DBA HealthFirst | 5726eeca-db88-ba8e-e063-6294a90a927d | 2026-08-03 | Warnings, Adverse reactions | EPINEPHRINE EPINEPHRINE |
| EPINEPHRINE | EPINEPHRINE | HF Acquisition Co LLC, DBA HealthFirst | 5725a519-3ad6-7e5e-e063-6394a90a111f | 2026-07-21 | Warnings, Adverse reactions | EPINEPHRINE EPINEPHRINE |
| EPINEPHRINE | EPINEPHRINE | Fresenius Kabi USA, LLC | 4f83895f-638c-4515-af03-7c41ae60a42e | 2026-07-15 | Warnings, Adverse reactions | EPINEPHRINE EPINEPHRINE |
| Epinephrine | EPINEPHRINE | A-S Medication Solutions | 6e811e28-0199-4df7-a916-5940c632401d | 2026-07-13 | Warnings, Adverse reactions | Epinephrine EPINEPHRINE |
| EPINEPHRINE | EPINEPHRINE | CIVICA, INC. | 4a79ad00-405b-4454-a692-7f1daac4adec | 2026-07-10 | Warnings, Adverse reactions | EPINEPHRINE EPINEPHRINE |
| Epinephrine | EPINEPHRINE | A-S Medication Solutions | 386519ba-7a44-4edd-9eb1-748419b7a71b | 2026-07-06 | Warnings, Adverse reactions | Epinephrine EPINEPHRINE |
| Adrenalin | EPINEPHRINE | Par Health USA, LLC | 3b7a4364-668d-4eb2-a20c-04adc35aabe4 | 2026-07-01 | Warnings, Adverse reactions | EPINEPHRINE |
| Adrenalin | EPINEPHRINE | REMEDYREPACK INC. | 1d89cba4-432b-4a98-8969-5a019dced8d1 | 2026-06-16 | Warnings, Adverse reactions | EPINEPHRINE |
| Epinephrine | EPINEPHRINE | REMEDYREPACK INC. | 0172280c-f7d6-4613-9dbd-f94d3ae5825a | 2026-06-08 | Warnings, Adverse reactions | Epinephrine EPINEPHRINE |
| Epinephrine | EPINEPHRINE | Hikma Pharmaceuticals USA Inc. | 1e8ebac1-5b32-47f9-a930-86a98a24dccc | 2026-05-05 | Warnings, Adverse reactions | Epinephrine EPINEPHRINE |
| Epinephrine | EPINEPHRINE | Sportpharm LLC | 3a8f5ca2-6c1d-4011-9266-ba93c7a3abb9 | 2026-04-24 | Warnings, Adverse reactions | Epinephrine EPINEPHRINE |
| neffy | EPINEPHRINE | Sportpharm LLC | 2052f9db-7d76-443b-b702-b6b499f9a4b8 | 2026-04-24 | Warnings, Adverse reactions | EPINEPHRINE |
| neffy | EPINEPHRINE | ARS Pharmaceuticals Operations, Inc. | a1758142-a905-401d-8961-05829f51023a | 2026-04-09 | Warnings, Adverse reactions | EPINEPHRINE |
| Adrenalin | EPINEPHRINE | Par Health USA, LLC | a5ce0c01-dd47-4997-ab09-490de65d3835 | 2026-04-08 | Warnings, Adverse reactions | EPINEPHRINE |
| Adrenalin | EPINEPHRINE | Par Health USA, LLC | b27e06aa-5b40-44bc-8de7-80b027580a3b | 2026-04-08 | Warnings, Adverse reactions | EPINEPHRINE |
| epinephrine | EPINEPHRINE | Baxter Healthcare Corporation | ef556382-9d19-4f0e-9dbe-fcecc772a3e2 | 2026-03-30 | Warnings, Adverse reactions | epinephrine EPINEPHRINE |
| epinephrine | EPINEPHRINE | REMEDYREPACK INC. | c66de0d3-3b0f-4e52-a712-60357a107676 | 2026-03-24 | Warnings, Adverse reactions | epinephrine EPINEPHRINE |
| epinephrine | EPINEPHRINE | Amneal Pharmaceuticals of New York LLC | e13f05f1-7d21-49bb-b8d5-24bf9301c3d7 | 2026-03-20 | Warnings, Adverse reactions | epinephrine EPINEPHRINE |
| epinephrine | EPINEPHRINE | Baxter Healthcare Corporation | 60efd409-3555-4182-a68d-1cd7bc0d1bfc | 2026-03-16 | Warnings, Adverse reactions | epinephrine EPINEPHRINE |
| epinephrine | EPINEPHRINE | REMEDYREPACK INC. | bfc7ab3d-1e0e-4fd9-b6df-09603eb5808c | 2026-02-18 | Warnings, Adverse reactions | epinephrine EPINEPHRINE |