FDA Orange Book · active-ingredient family
Dantrolene sodium
Dantrolene sodium: 3 brands, 5 generics; first approved Mar 01, 2005; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 5 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
5
Listed patents
0
Presentations
14
Brand (NDA) products
Originator applications
- EAGLE PHARMSNDA 2055792014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/VIAL FOR SUSPENSION INTRAVENOUS Rx — - DANTRIUMRLDPH HEALTHNDA 017443—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB - PH HEALTHNDA 018264—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/VIAL INJECTABLE INJECTION Rx AP
Generic (ANDA) products (5)
Abbreviated applications
- DANTROLENE SODIUMHIKMAANDA 2047622017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/VIAL INJECTABLE INJECTION Rx AP - DANTROLENE SODIUMEUGIA PHARMA SPECLTSANDA 2052392016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/VIAL INJECTABLE INJECTION Discontinued — - USWMANDA 0783782007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/VIAL INJECTABLE INJECTION Rx AP - DANTROLENE SODIUMELITE LABS INCANDA 07668620053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB - DANTROLENE SODIUMIMPAX LABSANDA 07685620053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
21 yr 10 mo ago
Most recent approval
9 yr 4 mo ago
Approvals span 2005–2017 across 8 FDA applications.
Brand (NDA) 338%
Generic (ANDA) 563%
Dantrolene sodium: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
