Application 205239
- Type
- ANDA
- Sponsor
- MYLAN INSTITUTIONAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DANTROLENE SODIUM | DANTROLENE SODIUM | INJECTABLE;INJECTION | 20MG/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205239-001 | DANTROLENE SODIUM | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 |
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 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A205239-001 | DANTROLENE SODIUM | 20MG/VIAL | INJECTABLE / INJECTION | 2016-02-18 | 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 |
|---|---|---|---|---|---|---|
| Dantrolene Sodium | DANTROLENE SODIUM | Major Pharmaceuticals | 90414d2f-7b2c-47f9-a096-2e7b7dd052de | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | Dantrolene Sodium DANTROLENE SODIUM |
| dantrolene sodium | DANTROLENE SODIUM | REMEDYREPACK INC. | 35f62a81-653f-4a3c-a797-d39304dcd08c | 2026-06-02 | Boxed warning, Warnings, Adverse reactions | dantrolene sodium DANTROLENE SODIUM |
| Dantrolene Sodium | DANTROLENE SODIUM | Amneal Pharmaceuticals of New York LLC | c3c45b27-f786-456e-95d6-2e38ef36190a | 2026-05-12 | Boxed warning, Warnings, Adverse reactions | Dantrolene Sodium DANTROLENE SODIUM |
| dantrolene sodium | DANTROLENE SODIUM | REMEDYREPACK INC. | c10e7eb1-0155-43ff-aa56-8cd468e8e84d | 2026-04-24 | Boxed warning, Warnings, Adverse reactions | dantrolene sodium DANTROLENE SODIUM |
| Dantrium | DANTROLENE SODIUM | Par Health USA, LLC | 4df35098-8702-46be-ac67-30cfdf1aa570 | 2026-03-10 | Warnings, Adverse reactions | DANTROLENE SODIUM |
| Revonto | DANTROLENE SODIUM | ProPharma Distribution | 3edcfad5-00ad-7587-e063-6394a90addf3 | 2025-12-18 | Warnings, Adverse reactions | DANTROLENE SODIUM |
| Dantrolene Sodium | DANTROLENE SODIUM | Cardinal Health 107, LLC | 5ec05285-4cbd-49c4-951b-86829da6f587 | 2025-09-30 | Boxed warning, Warnings, Adverse reactions | Dantrolene Sodium DANTROLENE SODIUM |
| Dantrolene Sodium | DANTROLENE SODIUM | AvPAK | bd1ef298-2219-2a01-e053-2995a90abb08 | 2025-04-17 | Boxed warning, Warnings, Adverse reactions | Dantrolene Sodium DANTROLENE SODIUM |
| dantrolene sodium | DANTROLENE SODIUM | Endo USA, Inc. | 11689f56-15e0-4350-b53f-ae96e5994fea | 2024-12-22 | Boxed warning, Warnings, Adverse reactions | dantrolene sodium DANTROLENE SODIUM |
| Dantrium | DANTROLENE SODIUM | Endo USA, Inc. | 57b4eec1-49e1-432c-95ae-0fe36e32d64b | 2024-12-19 | Boxed warning, Warnings, Adverse reactions | DANTROLENE SODIUM |
| RYANODEX dantrolene sodium | DANTROLENE SODIUM | Eagle Pharmaceuticals, Inc. | 8f7b3ac0-604d-4c78-b545-5e0f8ea3d698 | 2024-10-30 | Warnings, Adverse reactions | DANTROLENE SODIUM |
| Dantrolene Sodium | DANTROLENE SODIUM | American Health Packaging | 5162f162-8454-4c07-9670-682df7c30b0f | 2024-10-29 | Boxed warning, Warnings, Adverse reactions | Dantrolene Sodium DANTROLENE SODIUM |
| Dantrolene Sodium | DANTROLENE SODIUM | Bryant Ranch Prepack | e432a760-40b8-4efa-af2b-18e027ac5ae4 | 2024-08-20 | Boxed warning, Warnings, Adverse reactions | Dantrolene Sodium DANTROLENE SODIUM |
| Dantrolene Sodium | DANTROLENE SODIUM | Bryant Ranch Prepack | dbf78d48-71a6-4a9b-bf31-e710b78944f2 | 2024-08-15 | Boxed warning, Warnings, Adverse reactions | Dantrolene Sodium DANTROLENE SODIUM |
| Dantrolene Sodium | DANTROLENE SODIUM | Bryant Ranch Prepack | bd218ddb-c133-438c-9545-321ae4b52440 | 2024-08-15 | Boxed warning, Warnings, Adverse reactions | Dantrolene Sodium DANTROLENE SODIUM |
| dantrolene sodium | DANTROLENE SODIUM | Bryant Ranch Prepack | f6ce8871-f1a5-43ea-9250-1999fb69b835 | 2024-08-06 | Boxed warning, Warnings, Adverse reactions | dantrolene sodium DANTROLENE SODIUM |
| Revonto | DANTROLENE SODIUM | USWM, LLC | f1650487-32bd-4017-b9c2-b38829a531af | 2024-05-14 | Warnings, Adverse reactions | DANTROLENE SODIUM |
| dantrolene sodium | DANTROLENE SODIUM | Bryant Ranch Prepack | db715aef-83ca-4608-befa-8288ab4adeea | 2024-03-22 | Boxed warning, Warnings, Adverse reactions | dantrolene sodium DANTROLENE SODIUM |
| dantrolene sodium | DANTROLENE SODIUM | Bryant Ranch Prepack | c83daa7b-f2c6-418f-a242-fe2d8cad4081 | 2023-10-03 | Boxed warning, Warnings, Adverse reactions | dantrolene sodium DANTROLENE SODIUM |
| Dantrolene Sodium | DANTROLENE SODIUM | Elite Laboratories, Inc. | e637fb20-6a17-4522-810a-990bf1409732 | 2019-12-27 | Boxed warning, Warnings, Adverse reactions | Dantrolene Sodium DANTROLENE SODIUM |