Assyro AI

FDA Orange Book · active-ingredient family

Hydroflumethiazide; reserpine

Hydroflumethiazide; reserpine is approved as 1 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:SALUTENSIN · NDA 012359

1

Brand (NDA)

5

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
SALUTENSIN×2SHIRENDA 012359Approved Prior to Jan 1, 1982

Generic (ANDA) products (5)

ProductApplicantApplicationTEApproved
RESERPINE AND HYDROFLUMETHIAZIDEPAR PHARMANDA 088907Sep 20, 1985
RESERPINE AND HYDROFLUMETHIAZIDEIVAX PHARMSANDA 088932Jan 11, 1985
HYDROFLUMETHIAZIDE AND RESERPINEUSL PHARMAANDA 088195Oct 26, 1983
HYDROFLUMETHIAZIDE AND RESERPINEWATSON LABSANDA 088127Mar 22, 1983
HYDROFLUMETHIAZIDE AND RESERPINEWATSON LABSANDA 088110Mar 22, 1983

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.

Hydroflumethiazide; 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.