Application 204200
- Type
- NDA
- Sponsor
- PAR STERILE PRODUCTS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ADRENALIN | EPINEPHRINE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N204200-001 | ADRENALIN | EPINEPHRINE | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2012-12-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N204200-001 | AP |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N204200-001 | 12280024 | 2035-03-13 | Drug product | 2025-04-25 | |
| N204200-001 | 9119876 | 2035-03-13 | Drug product | 2016-01-14 | |
| N204200-001 | 9295657 | 2035-03-13 | U-1829 | 2016-04-12 |
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 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2012-12-07 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2012-12-07 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2012-12-07 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2012-12-07 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2012-12-07 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2012-12-07 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2012-12-07 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2012-12-07 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N204200-001 | ADRENALIN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2012-12-07 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N204200-001 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204200-001 | AP | 1 | 31067a03dcf5… |
| 2019-07-19 19:46 UTC | 2019-07 | N204200-001 | AP | 1 | ea99ee380514… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N204200-001 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N204200-001 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N204200-001 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N204200-001 | AP | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N204200-001 | AP | 1 | 3a93d1ddd44b… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N204200-001 | AP | 1 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N204200-001 | 12280024 | 2035-03-13 | Drug product | 2025-04-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204200-001 | 9119876 | 2035-03-13 | Drug product | 2016-01-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204200-001 | 9295657 | 2035-03-13 | U-1829 | 2016-04-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204200-001 | 12280024 | 2035-03-13 | Drug product | 2025-04-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204200-001 | 9119876 | 2035-03-13 | Drug product | 2016-01-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204200-001 | 9295657 | 2035-03-13 | U-1829 | 2016-04-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204200-001 | 12280024 | 2035-03-13 | Drug product | 2025-04-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204200-001 | 9119876 | 2035-03-13 | Drug product | 2016-01-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204200-001 | 9295657 | 2035-03-13 | U-1829 | 2016-04-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204200-001 | 9119876 | 2035-03-13 | Drug product | 2016-01-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204200-001 | 9295657 | 2035-03-13 | U-1829 | 2016-04-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204200-001 | 9119876 | 2035-03-13 | Drug product | 2016-01-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204200-001 | 9295657 | 2035-03-13 | U-1829 | 2016-04-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204200-001 | 9119876 | 2035-03-13 | Drug product | 2016-01-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204200-001 | 9295657 | 2035-03-13 | U-1829 | 2016-04-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204200-001 | 9119876 | 2035-03-13 | Drug product | 2016-01-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204200-001 | 9295657 | 2035-03-13 | U-1829 | 2016-04-12 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204200-001 | 9119876 | 2035-03-13 | Drug product | 2016-01-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204200-001 | 9295657 | 2035-03-13 | U-1829 | 2016-04-12 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204200-001 | 9119876 | 2035-03-13 | Drug product | 2016-01-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204200-001 | 9295657 | 2035-03-13 | U-1829 | 2016-04-12 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N204200-001 | 9119876 | 2035-03-13 | Drug product | 2016-01-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N204200-001 | 9295657 | 2035-03-13 | U-1829 | 2016-04-12 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204200-001 | 9119876 | 2035-03-13 | Drug product | 2016-01-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204200-001 | 9295657 | 2035-03-13 | U-1829 | 2016-04-12 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N204200-001 | 9119876 | 2035-03-13 | Drug product | 2016-01-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N204200-001 | 9295657 | 2035-03-13 | U-1829 | 2016-04-12 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N204200-001 | 9119876 | 2035-03-13 | Drug product | 2016-01-14 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N204200-001 | 9295657 | 2035-03-13 | U-1829 | 2016-04-12 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N204200-001 | 9119876 | 2035-03-13 | Drug product | 2016-01-14 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N204200-001 | 9295657 | 2035-03-13 | U-1829 | 2016-04-12 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N204200-001 | 9119876 | 2035-03-13 | Drug product | 2016-01-14 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N204200-001 | 9295657 | 2035-03-13 | U-1829 | 2016-04-12 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N204200-001 | 9119876 | 2035-03-13 | Drug product | 2016-01-14 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N204200-001 | 9295657 | 2035-03-13 | U-1829 | 2016-04-12 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N204200-001 | 9119876 | 2035-03-13 | Drug product | 2016-01-14 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N204200-001 | 9295657 | 2035-03-13 | U-1829 | 2016-04-12 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N204200-001 | 9119876 | 2035-03-13 | Drug product | 2016-01-14 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N204200-001 | 9295657 | 2035-03-13 | U-1829 | 2016-04-12 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N204200-001 | 9119876 | 2035-03-13 | Drug product | 2016-01-14 | bb7c543d1eb4… |
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 |
|---|---|---|---|---|---|---|
| Adrenalin | EPINEPHRINE | Par Health USA, LLC | 3b7a4364-668d-4eb2-a20c-04adc35aabe4 | 2026-07-01 | Warnings, Adverse reactions | 204200 NDA204200 42023-159 |
| Adrenalin | EPINEPHRINE | REMEDYREPACK INC. | 1d89cba4-432b-4a98-8969-5a019dced8d1 | 2026-06-16 | Warnings, Adverse reactions | 204200 NDA204200 70518-1342 |
| Epinephrine Professional | EPINEPHRINE AND ISOPROPYL ALCOHOL | Focus Health Group | 8c502fcc-1b61-7d1f-e053-2a95a90adc46 | 2026-02-11 | 204200 NDA204200 24357-011 | |
| Adrenalin Vials | EPINEPHRINE | Sina Health Inc | 28649937-8ae1-a022-e063-6394a90aebe0 | 2026-01-12 | Warnings, Adverse reactions | 204200 NDA204200 |
| Adrenalin | EPINEPHRINE | ProPharma Distribution | 3eef2920-0129-6dc2-e063-6294a90ac22a | 2025-12-18 | Warnings, Adverse reactions | 204200 NDA204200 |
| Adrenalin | EPINEPRINE | Henry Schein, Inc. | b293ad8e-7055-4a95-a130-9d7d74f19eab | 2025-01-30 | Warnings, Adverse reactions | 204200 NDA204200 0404-9810 |
| Epinephrine Convenience Kit | EPINEPHRINE | HF Acquisition Co LLC, DBA HealthFirst | 9df23744-3b5b-5815-e053-2a95a90acc47 | 2025-01-08 | Warnings, Adverse reactions | 204200 NDA204200 51662-1507 |
| ADRENALIN (EPINEPHRINE) | ADRENALIN (EPINEPHRINE) | HF Acquisition Co LLC, DBA HealthFirst | 7663c49d-1b1d-755d-e053-2991aa0a4ee3 | 2024-02-22 | Warnings, Adverse reactions | 204200 NDA204200 51662-1290 |
| Adrenalin | EPINEPHRINE | Medical Purchasing Solutions, LLC | b622a9b9-2f09-46e4-e053-2995a90aae01 | 2023-05-04 | Warnings, Adverse reactions | 204200 NDA204200 71872-7223 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0404-9810 | Adrenalin | epineprine | Henry Schein, Inc. | NDA | Current |
| 0404-9810 | Adrenalin | epineprine | Henry Schein, Inc. | NDA | Current |
| 24357-011 | Epinephrine Professional | Epinephrine and Isopropyl Alcohol | Focus Health Group | NDA | Current |
| 24357-011 | Epinephrine Professional | Epinephrine and Isopropyl Alcohol | Focus Health Group | NDA | Current |
| 24357-011 | Epinephrine Professional | Epinephrine and Isopropyl Alcohol | Focus Health Group | NDA | Current |
| 24357-011 | Epinephrine Professional | Epinephrine and Isopropyl Alcohol | Focus Health Group | NDA | Current |
| 24357-012 | Epinephrine Professional EMS | Epinephrine Convenience Kit | Focus Health Group | NDA | Current |
| 24357-012 | Epinephrine Professional EMS | Epinephrine Convenience Kit | Focus Health Group | NDA | Current |
| 24357-012 | Epinephrine Professional EMS | Epinephrine Convenience Kit | Focus Health Group | NDA | Current |
| 24357-012 | Epinephrine Professional EMS | Epinephrine Convenience Kit | Focus Health Group | NDA | Current |
| 42023-159 | Adrenalin | epinephrine | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-159 | Adrenalin | epinephrine | Par Pharmaceutical, Inc. | NDA | Current |
| 51662-1290 | ADRENALIN (EPINEPHRINE) | ADRENALIN (EPINEPHRINE) | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1290 | ADRENALIN (EPINEPHRINE) | ADRENALIN (EPINEPHRINE) | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1290 | ADRENALIN (EPINEPHRINE) | ADRENALIN (EPINEPHRINE) | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1290 | ADRENALIN (EPINEPHRINE) | ADRENALIN (EPINEPHRINE) | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1290 | ADRENALIN (EPINEPHRINE) | ADRENALIN (EPINEPHRINE) | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1507 | EPINEPHRINE | EPINEPHRINE | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1507 | Epinephrine Convenience Kit | Epinephrine | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 52584-159 | Adrenalin | epineprine | General Injectables and Vaccines, Inc. | NDA | Current |
| 52584-159 | Adrenalin | epineprine | General Injectables and Vaccines, Inc. | NDA | Current |
| 52584-159 | Adrenalin | epineprine | General Injectables and Vaccines, Inc. | NDA | Current |
| 52584-159 | Adrenalin | epineprine | General Injectables and Vaccines, Inc. | NDA | Current |
| 52584-159 | Adrenalin | epineprine | General Injectables and Vaccines, Inc. | NDA | Current |
| 52584-159 | Adrenalin | epineprine | General Injectables and Vaccines, Inc. | NDA | Current |
| 70518-1342 | Adrenalin | epinephrine | REMEDYREPACK INC. | NDA | Current |
| 71754-001 | Certa Dose Epinephrine Convenience Kit | Epinephrine Convenience Kit | Certa Dose, Inc. | NDA | Current |
| 71754-001 | Certa Dose Epinephrine Convenience Kit | Epinephrine Convenience Kit | Certa Dose, Inc. | NDA | Current |
| 71754-001 | Certa Dose Epinephrine Convenience Kit | Epinephrine Convenience Kit | Certa Dose, Inc. | NDA | Current |
| 71754-001 | Certa Dose Epinephrine Convenience Kit | Epinephrine Convenience Kit | CD Acquisitions, LLC | NDA | Current |
| 71872-7223 | Adrenalin | epinephrine | Medical Purchasing Solutions, LLC | NDA | Current |
| 71923-100 | EpinephrineSnap-EMS | Epinephrine Convenience Kit | Snap Medical Industries | NDA | Current |
| 71923-100 | EpinephrineSnap-EMS | Epinephrine Convenience Kit | Snap Medical Industries | NDA | Current |
| 71923-100 | EpinephrineSnap-EMS | Epinephrine Convenience Kit | Snap Medical Industries | NDA | Current |
| 71923-100 | EpinephrineSnap-EMS | Epinephrine Convenience Kit | Snap Medical Industries | NDA | Current |
| 71923-200 | EpinephrineSnap-V | Epinephrine Convenience Kit | Snap Medical Industries | NDA | Current |
| 71923-200 | EpinephrineSnap-V | Epinephrine Convenience Kit | Snap Medical Industries | NDA | Current |
| 71923-200 | EpinephrineSnap-V | Epinephrine Convenience Kit | Snap Medical Industries | NDA | Current |
| 71923-200 | EpinephrineSnap-V | Epinephrine Convenience Kit | Snap Medical Industries | NDA | Current |
| 71923-300 | Epinephrine Convenience Kit | EpinephrineSnap | Snap Medical Industries, LCC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 73120 | SUPPL | 2023-01-09 |
| 73111 | SUPPL | 2023-01-06 |
| 61002 | SUPPL | 2019-11-20 |
| 57498 | SUPPL | 2019-02-11 |
| 57378 | SUPPL | 2019-01-30 |
| 49401 | SUPPL | 2017-08-15 |
| 49338 | SUPPL | 2017-08-11 |
| 47129 | SUPPL | 2017-02-07 |
| 47128 | SUPPL | 2017-02-07 |
| 40365 | SUPPL | 2016-05-20 |
| 10306 | SUPPL | 2016-05-19 |
| 44897 | ORIG | 2013-08-19 |
| 43458 | ORIG | 2013-08-19 |
| 32524 | ORIG | 2012-12-27 |
| 40364 | ORIG | 2012-12-10 |