FDA Orange Book · active-ingredient family
Fenoldopam mesylate
Fenoldopam mesylate: 1 brand, 4 generics; first approved Sep 23, 1997; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 4 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
4
Listed patents
0
Presentations
5
Brand (NDA) products
Originator applications
- CORLOPAMRLDHOSPIRANDA 0199221997
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (4)
Abbreviated applications
- FENOLDOPAM MESYLATETEVA PARENTERALANDA 0778262007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE/ML INJECTABLE INJECTION Discontinued — - FENOLDOPAM MESYLATESANDOZANDA 0771552005
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE/ML INJECTABLE INJECTION Discontinued — - FENOLDOPAM MESYLATEHIKMAANDA 0765822004
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE/ML INJECTABLE INJECTION Discontinued — - FENOLDOPAM MESYLATELUITPOLDANDA 0766562003
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE/ML INJECTABLE INJECTION 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
29 yr 4 mo ago
Most recent approval
19 yr 9 mo ago
Approvals span 1997–2007 across 5 FDA applications.
Brand (NDA) 120%
Generic (ANDA) 480%
Fenoldopam mesylate: 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.
