Assyro AI
FDA Orange Book · active-ingredient family

Cupric chloride

Cupric chloride: 1 brand, 4 generics; first approved Jun 26, 1986; generic available.

Generic availableHas discontinued products
Generic status & protection

Generic available — 4 ANDA applications approved.

Brands (NDA)
1
Generics (ANDA)
4
Listed patents
0
Presentations
5
Originator applications

Brand (NDA) products

NDA 0189601986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 0.4MG COPPER/MLINJECTABLEINJECTIONRxAP
Abbreviated applications

Generic (ANDA) products (4)

ANDA 2172872026
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 0.4MG COPPER/MLINJECTABLEINJECTIONDiscontinued
ANDA 2161132024
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 0.4MG COPPER/MLINJECTABLEINJECTIONRxAP
ANDA 2176262024
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 0.4MG COPPER/MLINJECTABLEINJECTIONRxAP
ANDA 2120712022
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 0.4MG COPPER/MLINJECTABLEINJECTIONRxAP
Orange Book patent file

Listed patents

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.

FDA approval span

Approval history

First approval
Jun 26, 1986
40 yr 8 mo ago
Most recent approval
Jan 26, 2026
6 mo ago

Approvals span 1986–2026 across 5 FDA applications.

Brand (NDA) 120%
Generic (ANDA) 480%

Cupric chloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Related FDA reference tools

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.