Application 215700
- Type
- NDA
- Sponsor
- INFORLIFE SA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE | NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE | INJECTABLE;INJECTION | 4MG(16MCG PER ML)0.9% | No | No |
| 002 | NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE | NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE | INJECTABLE;INJECTION | 8MG(32MCG PER ML)0.9% | No | No |
| 003 | NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE | NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE | INJECTABLE;INJECTION | 16MG(64MCG PER ML)0.9% | No | No |
| 004 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | NOREPINEPHRINE BITARTRATE | SOLUTION;INTRAVENOUS | EQ 32MG BASE/250ML (EQ 128MCG BASE/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N215700-001 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | NOREPINEPHRINE BITARTRATE | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | |
| N215700-002 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | NOREPINEPHRINE BITARTRATE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | |
| N215700-003 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | NOREPINEPHRINE BITARTRATE | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | |
| N215700-004 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | NOREPINEPHRINE BITARTRATE | EQ 32MG BASE/250ML (EQ 128MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-10-15 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N215700-001 | RE49422 | 2035-02-26 | Drug product | 2025-03-03 | |
| N215700-001 | 10888534 | 2039-04-26 | Drug product | 2022-09-21 | |
| N215700-002 | RE49422 | 2035-02-26 | Drug product | 2025-03-03 | |
| N215700-002 | 10888534 | 2039-04-26 | Drug product | 2022-09-21 | |
| N215700-003 | RE49422 | 2035-02-26 | Drug product | 2025-03-03 | |
| N215700-003 | RE49443 | 2035-02-26 | Drug product | 2025-03-03 | |
| N215700-003 | 10888534 | 2039-04-26 | Drug product | 2022-09-21 | |
| N215700-004 | RE49422 | 2035-02-26 | Drug product | 2026-01-22 | |
| N215700-004 | RE49443 | 2035-02-26 | Drug product | 2026-01-22 | |
| N215700-004 | 10888534 | 2039-04-26 | Drug product | 2026-01-22 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N215700-001 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N215700-002 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N215700-003 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N215700-004 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 32MG BASE/250ML (EQ 128MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-10-15 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N215700-001 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215700-002 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215700-003 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215700-004 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 32MG BASE/250ML (EQ 128MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-10-15 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N215700-001 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215700-002 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215700-003 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215700-004 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 32MG BASE/250ML (EQ 128MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-10-15 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215700-001 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215700-002 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215700-003 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215700-004 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 32MG BASE/250ML (EQ 128MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-10-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215700-001 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215700-002 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215700-003 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215700-004 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 32MG BASE/250ML (EQ 128MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-10-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215700-001 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215700-002 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215700-003 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215700-001 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215700-002 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215700-003 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215700-001 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215700-002 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215700-003 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215700-001 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215700-002 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215700-003 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215700-001 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215700-002 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215700-003 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215700-001 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215700-002 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215700-003 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215700-001 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215700-002 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-09-15 | d8e5a09893c0… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N215700-001 | RE49422 | 2035-02-26 | Drug product | 2025-03-03 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N215700-001 | 10888534 | 2039-04-26 | Drug product | 2022-09-21 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N215700-002 | RE49422 | 2035-02-26 | Drug product | 2025-03-03 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N215700-002 | 10888534 | 2039-04-26 | Drug product | 2022-09-21 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N215700-003 | RE49422 | 2035-02-26 | Drug product | 2025-03-03 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N215700-003 | RE49443 | 2035-02-26 | Drug product | 2025-03-03 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N215700-003 | 10888534 | 2039-04-26 | Drug product | 2022-09-21 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N215700-004 | RE49422 | 2035-02-26 | Drug product | 2026-01-22 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N215700-004 | RE49443 | 2035-02-26 | Drug product | 2026-01-22 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N215700-004 | 10888534 | 2039-04-26 | Drug product | 2026-01-22 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N215700-001 | RE49422 | 2035-02-26 | Drug product | 2025-03-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215700-001 | 10888534 | 2039-04-26 | Drug product | 2022-09-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215700-002 | RE49422 | 2035-02-26 | Drug product | 2025-03-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215700-002 | 10888534 | 2039-04-26 | Drug product | 2022-09-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215700-003 | RE49422 | 2035-02-26 | Drug product | 2025-03-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215700-003 | RE49443 | 2035-02-26 | Drug product | 2025-03-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215700-003 | 10888534 | 2039-04-26 | Drug product | 2022-09-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215700-004 | RE49422 | 2035-02-26 | Drug product | 2026-01-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215700-004 | RE49443 | 2035-02-26 | Drug product | 2026-01-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215700-004 | 10888534 | 2039-04-26 | Drug product | 2026-01-22 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N215700-001 | RE49422 | 2035-02-26 | Drug product | 2025-03-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215700-001 | 10888534 | 2039-04-26 | Drug product | 2022-09-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215700-002 | RE49422 | 2035-02-26 | Drug product | 2025-03-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215700-002 | 10888534 | 2039-04-26 | Drug product | 2022-09-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215700-003 | RE49422 | 2035-02-26 | Drug product | 2025-03-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215700-003 | RE49443 | 2035-02-26 | Drug product | 2025-03-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215700-003 | 10888534 | 2039-04-26 | Drug product | 2022-09-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215700-004 | RE49422 | 2035-02-26 | Drug product | 2026-01-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215700-004 | RE49443 | 2035-02-26 | Drug product | 2026-01-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215700-004 | 10888534 | 2039-04-26 | Drug product | 2026-01-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215700-001 | RE49422 | 2035-02-26 | Drug product | 2025-03-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215700-001 | 10888534 | 2039-04-26 | Drug product | 2022-09-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215700-002 | RE49422 | 2035-02-26 | Drug product | 2025-03-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215700-002 | 10888534 | 2039-04-26 | Drug product | 2022-09-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215700-003 | 10251848 | 2035-02-26 | Drug product | 2025-03-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215700-003 | RE49422 | 2035-02-26 | Drug product | 2025-03-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215700-003 | RE49443 | 2035-02-26 | Drug product | 2025-03-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215700-003 | 10888534 | 2039-04-26 | Drug product | 2022-09-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215700-004 | RE49422 | 2035-02-26 | Drug product | 2026-01-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215700-004 | RE49443 | 2035-02-26 | Drug product | 2026-01-22 | 011fe1cb6892… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 44567-640 | NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | WG Critical Care, LLC | NDA | Current |
| 44567-640 | NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | WG Critical Care, LLC | NDA | Current |
| 44567-640 | NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | WG Critical Care, LLC | NDA | Current |
| 44567-641 | NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | WG Critical Care, LLC | NDA | Current |
| 44567-641 | NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | WG Critical Care, LLC | NDA | Current |
| 44567-641 | NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | WG Critical Care, LLC | NDA | Current |
| 44567-642 | NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | WG Critical Care, LLC | NDA | Current |
| 44567-642 | NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | WG Critical Care, LLC | NDA | Current |
| 44567-642 | NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | WG Critical Care, LLC | NDA | Current |