Assyro AI

FDA Orange Book · active-ingredient family

Piperazine citrate

Piperazine citrate is approved as 3 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ANTEPAR · NDA 009102

3

Brand (NDA)

5

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · syrup, tablet

ProductApplicantApplicationTEApproved
ANTEPAR×2GLAXOSMITHKLINENDA 009102Approved Prior to Jan 1, 1982
BRYRELSANOFI AVENTIS USNDA 017796Approved Prior to Jan 1, 1982
MULTIFUGEBLULINENDA 009452Approved Prior to Jan 1, 1982

Generic (ANDA) products (5)

ProductApplicantApplicationTEApproved
PIPERAZINE CITRATEALPHARMA US PHARMSANDA 080774Approved Prior to Jan 1, 1982
PIPERAZINE CITRATELANNETTANDA 080963Approved Prior to Jan 1, 1982
PIPERAZINE CITRATELUITPOLDANDA 080671Approved Prior to Jan 1, 1982
VERMIDOLSOLVAYANDA 080992Approved Prior to Jan 1, 1982
PIPERAZINE CITRATEIMPAX LABSANDA 080874Approved 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.

Piperazine citrate — frequently asked questions

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

Agent CTA Background

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