Application 008847
- Type
- NDA
- Sponsor
- APOTHECON
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SUCOSTRIN | SUCCINYLCHOLINE CHLORIDE | INJECTABLE;INJECTION | 20MG/ML | No | No |
| 003 | SUCOSTRIN | SUCCINYLCHOLINE CHLORIDE | INJECTABLE;INJECTION | 100MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N008847-001 | SUCOSTRIN | SUCCINYLCHOLINE CHLORIDE | 20MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| N008847-003 | SUCOSTRIN | SUCCINYLCHOLINE CHLORIDE | 100MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N008847-001 | SUCOSTRIN | 20MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N008847-003 | SUCOSTRIN | 100MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N008847-001 | SUCOSTRIN | 20MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N008847-003 | SUCOSTRIN | 100MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N008847-001 | SUCOSTRIN | 20MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N008847-003 | SUCOSTRIN | 100MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N008847-001 | SUCOSTRIN | 20MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N008847-003 | SUCOSTRIN | 100MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N008847-001 | SUCOSTRIN | 20MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N008847-003 | SUCOSTRIN | 100MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N008847-001 | SUCOSTRIN | 20MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N008847-003 | SUCOSTRIN | 100MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N008847-001 | SUCOSTRIN | 20MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N008847-003 | SUCOSTRIN | 100MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N008847-001 | SUCOSTRIN | 20MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N008847-003 | SUCOSTRIN | 100MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N008847-001 | SUCOSTRIN | 20MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N008847-003 | SUCOSTRIN | 100MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N008847-001 | SUCOSTRIN | 20MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N008847-003 | SUCOSTRIN | 100MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N008847-001 | SUCOSTRIN | 20MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N008847-003 | SUCOSTRIN | 100MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N008847-001 | SUCOSTRIN | 20MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N008847-003 | SUCOSTRIN | 100MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N008847-001 | SUCOSTRIN | 20MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N008847-003 | SUCOSTRIN | 100MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N008847-001 | SUCOSTRIN | 20MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N008847-003 | SUCOSTRIN | 100MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N008847-001 | SUCOSTRIN | 20MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N008847-003 | SUCOSTRIN | 100MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N008847-001 | SUCOSTRIN | 20MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N008847-003 | SUCOSTRIN | 100MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N008847-001 | SUCOSTRIN | 20MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N008847-003 | SUCOSTRIN | 100MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N008847-001 | SUCOSTRIN | 20MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N008847-003 | SUCOSTRIN | 100MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N008847-001 | SUCOSTRIN | 20MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N008847-003 | SUCOSTRIN | 100MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N008847-001 | SUCOSTRIN | 20MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N008847-003 | SUCOSTRIN | 100MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| Succinylcholine Chloride | SUCCINYLCHOLINE CHLORIDE | REMEDYREPACK INC. | efe5a242-5ba0-4b14-844c-206a79850d81 | 2026-09-10 | Boxed warning, Warnings, Adverse reactions | SUCCINYLCHOLINE CHLORIDE |
| QUELICIN | SUCCINYLCHOLINE CHLORIDE | Hospira, Inc. | fb08161e-7711-406d-e7b3-ea4515c07983 | 2026-08-18 | Boxed warning, Warnings, Adverse reactions | SUCCINYLCHOLINE CHLORIDE |
| Succinylcholine Chloride | SUCCINYLCHOLINE CHLORIDE | Somerset Therapeutics, LLC | 690a0231-dbba-4695-a843-842a14c6587c | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | SUCCINYLCHOLINE CHLORIDE |
| Succinylcholine Chloride | SUCCINYLCHOLINE CHLORIDE | Somerset Therapeutics, LLC | 499a4ba0-d466-4342-88da-9f1eb6098692 | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | SUCCINYLCHOLINE CHLORIDE |
| Succinylcholine Chloride | SUCCINYLCHOLINE CHLORIDE | Nordic Pharma, Inc. | 1e5891e2-e1e4-4587-b32c-b2e8082df9b6 | 2026-01-21 | Boxed warning, Warnings, Adverse reactions | SUCCINYLCHOLINE CHLORIDE |
| Succinylcholine Chloride | SUCCINYLCHOLINE CHLORIDE | STERISCIENCE SPECIALTIES PRIVATE LIMITED | 1d4302db-a0d5-d0e8-e063-6294a90a22f8 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | SUCCINYLCHOLINE CHLORIDE |
| SUCCINYLCHOLINE CHLORIDE | SUCCINYLCHOLINE CHLORIDE | Henry Schein, Inc. | 7d0f0431-e616-49c2-80d8-0752a45428db | 2025-11-07 | Boxed warning, Warnings, Adverse reactions | SUCCINYLCHOLINE CHLORIDE |
| Succinylcholine Chloride | SUCCINYLCHOLINE CHLORIDE | Piramal Critical Care Inc | b94ff0a2-a770-47a6-e053-2995a90a7fbc | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | SUCCINYLCHOLINE CHLORIDE |
| Succinylcholine Chloride | SUCCINYLCHOLINE CHLORIDE | Meitheal Pharmaceuticals Inc. | e21bff70-5247-4763-b984-b939eb0a1fc1 | 2025-09-26 | Boxed warning, Warnings, Adverse reactions | SUCCINYLCHOLINE CHLORIDE |
| Succinylcholine Chloride | SUCCINYLCHOLINE CHLORIDE | ProPharma Distribution | 386a63e7-d062-a4c7-e063-6394a90ae77c | 2025-07-18 | Boxed warning, Warnings, Adverse reactions | SUCCINYLCHOLINE CHLORIDE |
| Succinylcholine Chloride | SUCCINYLCHOLINE CHLORIDE | Fresenius Kabi USA LLC | f4d496fb-588f-459d-b218-0fc0ffa2715f | 2025-06-05 | Boxed warning, Warnings, Adverse reactions | SUCCINYLCHOLINE CHLORIDE |
| Succinylcholine Chloride | SUCCINYLCHOLINE CHLORIDE | Fresenius Kabi USA LLC | ce12d907-eae4-4fba-b85e-170fac1819c6 | 2025-06-05 | Boxed warning, Warnings, Adverse reactions | SUCCINYLCHOLINE CHLORIDE |
| Succinylcholine Chloride | SUCCINYLCHOLINE CHLORIDE | Devatis, Inc. | e235eb7d-5ce2-4884-9d16-493c90d7beba | 2024-11-30 | Boxed warning, Warnings, Adverse reactions | SUCCINYLCHOLINE CHLORIDE |
| Succinylcholine Chloride | SUCCINYLCHOLINE CHLORIDE | Camber Pharmaceuticals, Inc. | 3deac02b-392c-4ee4-9abf-7fe5b8975147 | 2024-10-16 | Boxed warning, Warnings, Adverse reactions | SUCCINYLCHOLINE CHLORIDE |
| SUCCINYLCHOLINE CHLORIDE | SUCCINYLCHOLINE CHLORIDE | Baxter Healthcare Corporation | 30f58922-3c74-4813-ace0-fcd2024acd09 | 2024-06-21 | Boxed warning, Warnings, Adverse reactions | SUCCINYLCHOLINE CHLORIDE |
| SUCCINYLCHOLINE CHLORIDE | SUCCINYLCHOLINE CHLORIDE | Fresenius Kabi USA, LLC | 4e2d3394-c9e0-4191-ba0d-da21034c22b5 | 2024-01-15 | Boxed warning, Warnings, Adverse reactions | SUCCINYLCHOLINE CHLORIDE |
| Succinylcholine Chloride | SUCCINYLCHOLINE CHLORIDE | BE Pharmaceuticals Inc. | 6e6e0ce7-c73c-407f-9678-724425f24976 | 2023-12-19 | Boxed warning, Warnings, Adverse reactions | SUCCINYLCHOLINE CHLORIDE |
| Anectine | SUCCINYLCHOLINE CHLORIDE | Sandoz Inc | a1e5d29f-111e-4a44-addf-beeb6ea81711 | 2023-11-29 | Boxed warning, Warnings, Adverse reactions | SUCCINYLCHOLINE CHLORIDE |
| Anectine | SUCCINYLCHOLINE CHLORIDE | Civica, Inc. | 0b990f84-9515-44bd-a97d-a97bbead065c | 2023-11-29 | Boxed warning, Warnings, Adverse reactions | SUCCINYLCHOLINE CHLORIDE |
| Anectine | SUCCINYLCHOLINE CHLORIDE | Sandoz Inc | 04a4e6f5-6fa1-42e1-a3f9-21fca7786b15 | 2023-11-29 | Boxed warning, Warnings, Adverse reactions | SUCCINYLCHOLINE CHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.