FDA Orange Book · active-ingredient family
Mesna
Mesna: 2 brands, 9 generics; first approved Dec 30, 1988; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 9 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
9
Listed patents
0
Presentations
11
Brand (NDA) products
Originator applications
Generic (ANDA) products (9)
Abbreviated applications
- MESNAEUGIA PHARMAANDA 2205182026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INTRAVENOUS Rx AP - MESNAINGENUS PHARMS LLCANDA 2188712025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Rx AB - MESNAGLANDANDA 2069922017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INTRAVENOUS Rx AP - MESNARISINGANDA 2033642014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INTRAVENOUS Discontinued — - MESNAMYLAN INSTITUTIONALANDA 0764882012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INTRAVENOUS Discontinued — - MESNASAGENT PHARMS INCANDA 0909132010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INTRAVENOUS Rx AP - MESNAHIKMAANDA 0757392004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INTRAVENOUS Rx AP - MESNATEVA PHARMS USAANDA 0757642001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INTRAVENOUS Discontinued — - MESNAFRESENIUS KABI USAANDA 0758112001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INTRAVENOUS Rx AP
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
38 yr 4 mo ago
Most recent approval
8 mo ago
Approvals span 1988–2026 across 11 FDA applications.
Brand (NDA) 218%
Generic (ANDA) 982%
Mesna: 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.
