Assyro AI

FDA Orange Book · active-ingredient family

Pralidoxime chloride

Pralidoxime chloride is approved in 4 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

4

Brand (NDA)

0

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, solution, tablet

ProductApplicantApplicationTEApproved
PRALIDOXIME CHLORIDE (AUTOINJECTOR)RLDMERIDIAN MEDCL TECHNNDA 018986Apr 26, 1983
PROTOPAM CHLORIDERLDBAXTER HLTHCARE CORPNDA 014134Approved Prior to Jan 1, 1982
PRALIDOXIME CHLORIDEBAXTER HLTHCARE CORPNDA 018799Dec 13, 1982
PROTOPAM CHLORIDEWYETH AYERSTNDA 014122Approved 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.

Pralidoxime chloride — 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.