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FDA Orange Book · active-ingredient family

Cupric chloride

Cupric chloride is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

1

Brand (NDA)

4

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable

ProductApplicantApplicationTEApproved
CUPRIC CHLORIDE IN PLASTIC CONTAINERRLDHOSPIRANDA 018960APJun 26, 1986

Generic (ANDA) products (4)

ProductApplicantApplicationTEApproved
CUPRIC CHLORIDEAMNEALANDA 217287Jan 26, 2026
CUPRIC CHLORIDESOMERSETANDA 216113APApr 30, 2024
CUPRIC CHLORIDESTIRAANDA 217626APApr 30, 2024
CUPRIC CHLORIDEEXELA PHARMAANDA 212071APOct 31, 2022

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.

Cupric 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.