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
HOSPIRANDA 0189601986
HOSPIRANDA 0189601986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| EQ 0.4MG COPPER/ML | INJECTABLE | INJECTION | Rx | AP |
Abbreviated applications
Generic (ANDA) products (4)
AMNEALANDA 2172872026
AMNEALANDA 2172872026
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| EQ 0.4MG COPPER/ML | INJECTABLE | INJECTION | Discontinued | — |
SOMERSETANDA 2161132024
SOMERSETANDA 2161132024
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| EQ 0.4MG COPPER/ML | INJECTABLE | INJECTION | Rx | AP |
STIRAANDA 2176262024
STIRAANDA 2176262024
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| EQ 0.4MG COPPER/ML | INJECTABLE | INJECTION | Rx | AP |
EXELA PHARMAANDA 2120712022
EXELA PHARMAANDA 2120712022
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| EQ 0.4MG COPPER/ML | INJECTABLE | INJECTION | Rx | AP |
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
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.

