FDA.reportPublic FDA data

Application 017443

Type
NDA
Sponsor
PAR STERILE PRODUCTS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DANTRIUMDANTROLENE SODIUMCAPSULE;ORAL25MGYesNo
002DANTRIUMDANTROLENE SODIUMCAPSULE;ORAL100MGYesYes
003DANTRIUMDANTROLENE SODIUMCAPSULE;ORAL50MGYesNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017443-001DANTRIUMDANTROLENE SODIUM25MGCAPSULE / ORALABRLD, Approved before 1982
N017443-002DANTRIUMDANTROLENE SODIUM100MGCAPSULE / ORALABRLD, RS, Approved before 1982
N017443-003DANTRIUMDANTROLENE SODIUM50MGCAPSULE / ORALABRLD, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N017443-001AB
N017443-002AB
N017443-003AB

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 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N017443-001DANTRIUM25MGCAPSULE / ORALABRLD, Approved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N017443-002DANTRIUM100MGCAPSULE / ORALABRLD, RS, Approved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N017443-003DANTRIUM50MGCAPSULE / ORALABRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017443-001DANTRIUM25MGCAPSULE / ORALABRLD, Approved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N017443-002DANTRIUM100MGCAPSULE / ORALABRLD, RS, Approved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N017443-003DANTRIUM50MGCAPSULE / ORALABRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017443-001DANTRIUM25MGCAPSULE / ORALABRLD, Approved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017443-002DANTRIUM100MGCAPSULE / ORALABRLD, RS, Approved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017443-003DANTRIUM50MGCAPSULE / ORALABRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017443-001DANTRIUM25MGCAPSULE / ORALABRLD, Approved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017443-002DANTRIUM100MGCAPSULE / ORALABRLD, RS, Approved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017443-003DANTRIUM50MGCAPSULE / ORALABRLD, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N017443-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09N017443-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09N017443-003AB1c2088c7a36db…
2026-09-14 22:38:342026-08N017443-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N017443-002AB184e616aacf4f…
2026-09-14 22:38:342026-08N017443-003AB184e616aacf4f…
2026-08-18 06:07:402026-07N017443-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N017443-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N017443-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017443-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017443-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017443-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017443-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017443-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017443-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017443-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017443-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017443-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017443-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017443-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017443-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017443-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017443-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017443-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017443-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017443-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017443-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017443-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017443-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017443-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017443-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017443-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017443-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017443-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017443-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017443-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017443-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N017443-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N017443-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017443-001AB179d66fd596c7…

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 · 5 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 reactionsExact identifier
application applno (NDA): 017443
application number: NDA017443
ndc (product): 42023-124
ndc (product): 42023-125
dantrolene sodiumDANTROLENE SODIUMPar Health USA, LLC11689f56-15e0-4350-b53f-ae96e5994fea2026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 017443
application number: NDA017443
ndc (product): 49884-364
ndc (product): 49884-363
ndc (product): 49884-362
dantrolene sodiumDANTROLENE SODIUMBryant Ranch Prepackf6ce8871-f1a5-43ea-9250-1999fb69b8352024-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 017443
application number: NDA017443
ndc (product): 63629-2168
dantrolene sodiumDANTROLENE SODIUMBryant Ranch Prepackdb715aef-83ca-4608-befa-8288ab4adeea2024-03-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 017443
application number: NDA017443
ndc (product): 63629-2169
dantrolene sodiumDANTROLENE SODIUMBryant Ranch Prepackc83daa7b-f2c6-418f-a242-fe2d8cad40812023-10-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 017443
application number: NDA017443

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42023-124Dantriumdantrolene sodiumPar Pharmaceutical, Inc.NDACurrent
42023-124Dantriumdantrolene sodiumPar Pharmaceutical, Inc.NDACurrent
42023-125Dantriumdantrolene sodiumPar Pharmaceutical, Inc.NDACurrent
42023-125Dantriumdantrolene sodiumPar Pharmaceutical, Inc.NDACurrent
42023-144dantrolene sodiumdantrolene sodiumPar Pharmaceutical, Inc.NDA AUTHORIZED GENERICCurrent
49884-362dantrolene sodiumdantrolene sodiumPar Pharmaceutical, Inc.NDA AUTHORIZED GENERICCurrent
49884-363dantrolene sodiumdantrolene sodiumPar Pharmaceutical, Inc.NDA AUTHORIZED GENERICCurrent
49884-364dantrolene sodiumdantrolene sodiumPar Pharmaceutical, Inc.NDA AUTHORIZED GENERICCurrent
63629-2168dantrolene sodiumdantrolene sodiumBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2168dantrolene sodiumdantrolene sodiumBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2168dantrolene sodiumdantrolene sodiumBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2169dantrolene sodiumdantrolene sodiumBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2169dantrolene sodiumdantrolene sodiumBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2169dantrolene sodiumdantrolene sodiumBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2170dantrolene sodiumdantrolene sodiumBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2170dantrolene sodiumdantrolene sodiumBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
33270SUPPL2012-07-19
10994SUPPL2012-07-19
10993SUPPL2012-07-19
10992SUPPL2012-07-19
13142SUPPL2012-07-18
13141SUPPL2012-07-18
589SUPPL2012-07-18
588SUPPL2012-07-18