FDA Orange Book · active-ingredient family
Dimethyl sulfoxide
Dimethyl sulfoxide: 1 brand, 2 generics; first approved Nov 29, 2002; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 2 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
2
Listed patents
0
Presentations
3
Brand (NDA) products
Originator applications
- MYLAN INSTITUTIONALNDA 017788—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50% SOLUTION INTRAVESICAL Rx AT
Generic (ANDA) products (2)
Abbreviated applications
- DIMETHYL SULFOXIDESTIRAANDA 2201732026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50% SOLUTION INTRAVESICAL Rx AT - DIMETHYL SULFOXIDEMYLAN INSTITUTIONALANDA 0761852002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50% SOLUTION INTRAVESICAL Discontinued —
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
24 yr ago
Most recent approval
28 d ago
Approvals span 2002–2026 across 3 FDA applications.
Brand (NDA) 133%
Generic (ANDA) 267%
Dimethyl sulfoxide: 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.
