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FDA Orange Book · active-ingredient family

Fenoldopam mesylate

Fenoldopam mesylate is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CORLOPAM · NDA 019922

1

Brand (NDA)

4

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable

ProductApplicantApplicationTEApproved
CORLOPAMRLDHOSPIRANDA 019922Sep 23, 1997

Generic (ANDA) products (4)

ProductApplicantApplicationTEApproved
FENOLDOPAM MESYLATETEVA PARENTERALANDA 077826Mar 07, 2007
FENOLDOPAM MESYLATESANDOZANDA 077155Feb 15, 2005
FENOLDOPAM MESYLATEHIKMAANDA 076582Oct 12, 2004
FENOLDOPAM MESYLATELUITPOLDANDA 076656Dec 01, 2003

Listed patents

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.

Fenoldopam mesylate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.