Application 213994
- Type
- NDA
- Sponsor
- NEVAKAR INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EPHEDRINE SULFATE | EPHEDRINE SULFATE | INJECTABLE;INJECTION | 5MG/ML | Yes | No |
| 002 | EPHEDRINE SULFATE | EPHEDRINE SULFATE | SOLUTION;INTRAVENOUS | 25MG/5ML (5MG/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N213994-001 | EPHEDRINE SULFATE | EPHEDRINE SULFATE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | AP2 | RLD, RS | 2020-10-16 |
| N213994-002 | EPHEDRINE SULFATE | EPHEDRINE SULFATE | 25MG/5ML (5MG/ML) | SOLUTION / INTRAVENOUS | AP2 | RLD, RS | 2022-04-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N213994-001 | AP2 |
| N213994-002 | AP2 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N213994-001 | 10869845 | 2040-01-22 | Drug product | 2020-12-22 | |
| N213994-002 | 10869845 | 2040-01-22 | Drug product | 2022-05-19 | |
| N213994-002 | 12029710 | 2040-01-22 | U-3963 | 2024-07-16 |
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 | N213994-001 | EPHEDRINE SULFATE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | AP2 | RLD, RS | 2020-10-16 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N213994-002 | EPHEDRINE SULFATE | 25MG/5ML (5MG/ML) | SOLUTION / INTRAVENOUS | AP2 | RLD, RS | 2022-04-22 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213994-001 | EPHEDRINE SULFATE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | AP2 | RLD, RS | 2020-10-16 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213994-002 | EPHEDRINE SULFATE | 25MG/5ML (5MG/ML) | SOLUTION / INTRAVENOUS | AP2 | RLD, RS | 2022-04-22 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N213994-001 | EPHEDRINE SULFATE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | AP2 | RLD, RS | 2020-10-16 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N213994-002 | EPHEDRINE SULFATE | 25MG/5ML (5MG/ML) | SOLUTION / INTRAVENOUS | AP2 | RLD, RS | 2022-04-22 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213994-001 | EPHEDRINE SULFATE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2020-10-16 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213994-002 | EPHEDRINE SULFATE | 25MG/5ML (5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2022-04-22 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213994-001 | EPHEDRINE SULFATE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-10-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213994-002 | EPHEDRINE SULFATE | 25MG/5ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-04-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213994-001 | EPHEDRINE SULFATE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-10-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213994-002 | EPHEDRINE SULFATE | 25MG/5ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-04-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N213994-001 | EPHEDRINE SULFATE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-10-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N213994-002 | EPHEDRINE SULFATE | 25MG/5ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-04-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N213994-001 | EPHEDRINE SULFATE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-10-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N213994-002 | EPHEDRINE SULFATE | 25MG/5ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-04-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N213994-001 | EPHEDRINE SULFATE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-10-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N213994-002 | EPHEDRINE SULFATE | 25MG/5ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-04-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N213994-001 | EPHEDRINE SULFATE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-10-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N213994-002 | EPHEDRINE SULFATE | 25MG/5ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-04-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N213994-001 | EPHEDRINE SULFATE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-10-16 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N213994-002 | EPHEDRINE SULFATE | 25MG/5ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-04-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N213994-001 | EPHEDRINE SULFATE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-10-16 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N213994-002 | EPHEDRINE SULFATE | 25MG/5ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-04-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N213994-001 | EPHEDRINE SULFATE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-10-16 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N213994-002 | EPHEDRINE SULFATE | 25MG/5ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-04-22 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N213994-001 | EPHEDRINE SULFATE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-10-16 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N213994-002 | EPHEDRINE SULFATE | 25MG/5ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-04-22 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N213994-001 | EPHEDRINE SULFATE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-10-16 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N213994-002 | EPHEDRINE SULFATE | 25MG/5ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-04-22 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N213994-001 | EPHEDRINE SULFATE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-10-16 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N213994-001 | EPHEDRINE SULFATE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-10-16 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | N213994-001 | EPHEDRINE SULFATE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-10-16 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N213994-001 | EPHEDRINE SULFATE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-10-16 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N213994-001 | EPHEDRINE SULFATE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-10-16 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N213994-001 | EPHEDRINE SULFATE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-10-16 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N213994-001 | EPHEDRINE SULFATE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-10-16 | 8869cabd3fbd… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N213994-001 | EPHEDRINE SULFATE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-10-16 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N213994-002 | EPHEDRINE SULFATE | 25MG/5ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-04-22 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N213994-001 | EPHEDRINE SULFATE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-10-16 | 1c564ffb4f44… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N213994-001 | AP2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N213994-002 | AP2 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213994-001 | AP2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213994-002 | AP2 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N213994-001 | AP2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N213994-002 | AP2 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213994-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213994-002 | AP | 1 | fd3edfee7708… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N213994-001 | AP2 | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N213994-002 | AP2 | 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 | N213994-001 | 10869845 | 2040-01-22 | Drug product | 2020-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213994-002 | 10869845 | 2040-01-22 | Drug product | 2022-05-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213994-002 | 12029710 | 2040-01-22 | U-3963 | 2024-07-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213994-001 | 10869845 | 2040-01-22 | Drug product | 2020-12-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213994-002 | 10869845 | 2040-01-22 | Drug product | 2022-05-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213994-002 | 12029710 | 2040-01-22 | U-3963 | 2024-07-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213994-001 | 10869845 | 2040-01-22 | Drug product | 2020-12-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213994-002 | 10869845 | 2040-01-22 | Drug product | 2022-05-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213994-002 | 12029710 | 2040-01-22 | U-3963 | 2024-07-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213994-001 | 10869845 | 2040-01-22 | Drug product | 2020-12-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213994-002 | 10869845 | 2040-01-22 | Drug product | 2022-05-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213994-002 | 12029710 | 2040-01-22 | U-3963 | 2024-07-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213994-001 | 10869845 | 2040-01-22 | Drug product | 2020-12-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213994-002 | 10869845 | 2040-01-22 | Drug product | 2022-05-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213994-002 | 12029710 | 2040-01-22 | U-3963 | 2024-07-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213994-001 | 10869845 | 2040-01-22 | Drug product | 2020-12-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213994-002 | 10869845 | 2040-01-22 | Drug product | 2022-05-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213994-002 | 12029710 | 2040-01-22 | U-3963 | 2024-07-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N213994-001 | 10869845 | 2040-01-22 | Drug product | 2020-12-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N213994-002 | 10869845 | 2040-01-22 | Drug product | 2022-05-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N213994-002 | 12029710 | 2040-01-22 | U-3963 | 2024-07-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N213994-001 | 10869845 | 2040-01-22 | Drug product | 2020-12-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N213994-002 | 10869845 | 2040-01-22 | Drug product | 2022-05-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N213994-002 | 12029710 | 2040-01-22 | U-3963 | 2024-07-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N213994-001 | 10869845 | 2040-01-22 | Drug product | 2020-12-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N213994-002 | 10869845 | 2040-01-22 | Drug product | 2022-05-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N213994-002 | 12029710 | 2040-01-22 | U-3963 | 2024-07-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N213994-001 | 10869845 | 2040-01-22 | Drug product | 2020-12-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N213994-002 | 10869845 | 2040-01-22 | Drug product | 2022-05-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N213994-002 | 12029710 | 2040-01-22 | U-3963 | 2024-07-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N213994-001 | 10869845 | 2040-01-22 | Drug product | 2020-12-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N213994-002 | 10869845 | 2040-01-22 | Drug product | 2022-05-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N213994-002 | 12029710 | 2040-01-22 | U-3963 | 2024-07-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N213994-001 | 10869845 | 2040-01-22 | Drug product | 2020-12-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N213994-002 | 10869845 | 2040-01-22 | Drug product | 2022-05-19 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N213994-001 | 10869845 | 2040-01-22 | Drug product | 2020-12-22 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N213994-002 | 10869845 | 2040-01-22 | Drug product | 2022-05-19 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N213994-001 | 10869845 | 2040-01-22 | Drug product | 2020-12-22 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N213994-002 | 10869845 | 2040-01-22 | Drug product | 2022-05-19 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N213994-001 | 10869845 | 2040-01-22 | Drug product | 2020-12-22 | 5c6f7cd8ea54… |
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 |
|---|---|---|---|---|---|---|
| EPHEDRINE SULFATE | EPHEDRINE SULFATE | Par Health USA, LLC | a247857e-ba7b-4a37-b132-4ba9b0d1c4d1 | 2023-05-31 | Warnings, Adverse reactions | 213994 NDA213994 42023-243 |
| EPHEDRINE SULFATE | EPHEDRINE SULFATE | Par Health USA, LLC | 2c203482-8a04-40fc-93d2-74b30dec7742 | 2022-04-30 | Warnings, Adverse reactions | 213994 NDA213994 42023-253 42023-243 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42023-243 | EPHEDRINE SULFATE | Ephedrine Sulfate | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-243 | EPHEDRINE SULFATE | Ephedrine Sulfate | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-253 | EPHEDRINE SULFATE | Ephedrine Sulfate | Par Pharmaceutical, Inc. | NDA | Current |