FDA.reportPublic FDA data

Application 205239

Type
ANDA
Sponsor
MYLAN INSTITUTIONAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DANTROLENE SODIUMDANTROLENE SODIUMINJECTABLE;INJECTION20MG/VIALNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205239-001DANTROLENE SODIUMDANTROLENE SODIUM20MG/VIALINJECTABLE / INJECTION2016-02-18

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A205239-001DANTROLENE SODIUM20MG/VIALINJECTABLE / INJECTION2016-02-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205239-001DANTROLENE SODIUM20MG/VIALINJECTABLE / INJECTION2016-02-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205239-001DANTROLENE SODIUM20MG/VIALINJECTABLE / INJECTION2016-02-18cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205239-001DANTROLENE SODIUM20MG/VIALINJECTABLE / INJECTION2016-02-18a50c72e98297…

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.

Matched openFDA labels page 1 of 1 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DantriumDANTROLENE SODIUMPar Health USA, LLC57b4eec1-49e1-432c-95ae-0fe36e32d64b2026-08-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DANTROLENE SODIUM
dantrolene sodiumDANTROLENE SODIUMPar Health USA, LLC11689f56-15e0-4350-b53f-ae96e5994fea2026-08-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: dantrolene sodium
generic name: DANTROLENE SODIUM
Dantrolene SodiumDANTROLENE SODIUMMajor Pharmaceuticals90414d2f-7b2c-47f9-a096-2e7b7dd052de2026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dantrolene Sodium
generic name: DANTROLENE SODIUM
Dantrolene SodiumDANTROLENE SODIUMAmneal Pharmaceuticals of New York LLCc3c45b27-f786-456e-95d6-2e38ef36190a2026-05-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dantrolene Sodium
generic name: DANTROLENE SODIUM
DantriumDANTROLENE SODIUMPar Health USA, LLC4df35098-8702-46be-ac67-30cfdf1aa5702026-03-10Warnings, Adverse reactionsName fallback
generic name: DANTROLENE SODIUM
RevontoDANTROLENE SODIUMProPharma Distribution3edcfad5-00ad-7587-e063-6394a90addf32025-12-18Warnings, Adverse reactionsName fallback
generic name: DANTROLENE SODIUM
Dantrolene SodiumDANTROLENE SODIUMCardinal Health 107, LLC5ec05285-4cbd-49c4-951b-86829da6f5872025-09-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dantrolene Sodium
generic name: DANTROLENE SODIUM
Dantrolene SodiumDANTROLENE SODIUMAvPAKbd1ef298-2219-2a01-e053-2995a90abb082025-04-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dantrolene Sodium
generic name: DANTROLENE SODIUM
RYANODEX dantrolene sodiumDANTROLENE SODIUMEagle Pharmaceuticals, Inc.8f7b3ac0-604d-4c78-b545-5e0f8ea3d6982024-10-30Warnings, Adverse reactionsName fallback
generic name: DANTROLENE SODIUM
Dantrolene SodiumDANTROLENE SODIUMAmerican Health Packaging5162f162-8454-4c07-9670-682df7c30b0f2024-10-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dantrolene Sodium
generic name: DANTROLENE SODIUM
Dantrolene SodiumDANTROLENE SODIUMBryant Ranch Prepacke432a760-40b8-4efa-af2b-18e027ac5ae42024-08-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dantrolene Sodium
generic name: DANTROLENE SODIUM
Dantrolene SodiumDANTROLENE SODIUMBryant Ranch Prepackdbf78d48-71a6-4a9b-bf31-e710b78944f22024-08-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dantrolene Sodium
generic name: DANTROLENE SODIUM
Dantrolene SodiumDANTROLENE SODIUMBryant Ranch Prepackbd218ddb-c133-438c-9545-321ae4b524402024-08-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dantrolene Sodium
generic name: DANTROLENE SODIUM
dantrolene sodiumDANTROLENE SODIUMBryant Ranch Prepackf6ce8871-f1a5-43ea-9250-1999fb69b8352024-08-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: dantrolene sodium
generic name: DANTROLENE SODIUM
RevontoDANTROLENE SODIUMUSWM, LLCf1650487-32bd-4017-b9c2-b38829a531af2024-05-14Warnings, Adverse reactionsName fallback
generic name: DANTROLENE SODIUM
dantrolene sodiumDANTROLENE SODIUMBryant Ranch Prepackdb715aef-83ca-4608-befa-8288ab4adeea2024-03-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: dantrolene sodium
generic name: DANTROLENE SODIUM
dantrolene sodiumDANTROLENE SODIUMBryant Ranch Prepackc83daa7b-f2c6-418f-a242-fe2d8cad40812023-10-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: dantrolene sodium
generic name: DANTROLENE SODIUM
Dantrolene SodiumDANTROLENE SODIUMElite Laboratories, Inc.e637fb20-6a17-4522-810a-990bf14097322019-12-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dantrolene Sodium
generic name: DANTROLENE SODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
19630ORIG2016-03-04
32647ORIG2016-02-22