Assyro AI

FDA Orange Book · active-ingredient family

Calcium chloride; dextrose; potassium chloride; sodium chloride

Calcium chloride; dextrose; potassium chloride; sodium 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

ProductApplicantApplicationTEApproved
DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINERB BRAUNNDA 020000Apr 17, 1992
DEXTROSE 5% AND RINGER'S IN PLASTIC CONTAINERHOSPIRANDA 018254Approved Prior to Jan 1, 1982
DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINERB BRAUNNDA 018256Approved Prior to Jan 1, 1982
DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINERBAXTER HLTHCARENDA 016695Approved 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.

Calcium chloride; dextrose; potassium chloride; sodium 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.