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FDA Orange Book · active-ingredient family

Probenecid

Probenecid is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:BENEMID · NDA 007898

1

Brand (NDA)

7

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
BENEMIDRLDMERCKNDA 007898Approved Prior to Jan 1, 1982

Generic (ANDA) products (7)

ProductApplicantApplicationTEApproved
PROBENECIDRISINGANDA 217020ABNov 20, 2023
PROBENECIDIVAX SUB TEVA PHARMSANDA 083740May 09, 1984
PROBENECIDWATSON LABS TEVAANDA 084442ABMar 29, 1983
PROBENECIDWATSON LABSANDA 086150Apr 23, 1982
PROBALANLANNETTANDA 080966ABApproved Prior to Jan 1, 1982
PROBENECIDAUROBINDO PHARMA USAANDA 084211Approved Prior to Jan 1, 1982
PROBENECIDLEDERLEANDA 086917Approved Prior to Jan 1, 1982

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.

Probenecid — 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.