Assyro AI

FDA Orange Book · active-ingredient family

Chlorothiazide; reserpine

Chlorothiazide; reserpine is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DIUPRES-250 · NDA 011635

1

Brand (NDA)

6

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
DIUPRES-250×2MERCKNDA 011635Aug 26, 1987

Generic (ANDA) products (6)

ProductApplicantApplicationTEApproved
CHLOROTHIAZIDE AND RESERPINEHIKMAANDA 088557Dec 22, 1983
CHLOROTHIAZIDE AND RESERPINEHIKMAANDA 088365Dec 22, 1983
CHLOROTHIAZIDE W/ RESERPINEWATSON LABSANDA 088151Jun 09, 1983
CHLOROTHIAZIDE-RESERPINEPHARMOBEDIENTANDA 087744May 06, 1982
CHLOROTHIAZIDE-RESERPINEPHARMOBEDIENTANDA 087745May 06, 1982
CHLOROTHIAZIDE W/ RESERPINEWATSON LABSANDA 084853Approved 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.

Chlorothiazide; reserpine — 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.