FDA Orange Book · active-ingredient family
Cupric sulfate
Cupric sulfate: 1 brand, 2 generics; first approved May 05, 1987; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 2 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
2
Listed patents
0
Presentations
3
Brand (NDA) products
Originator applications
- CUPRIC SULFATERLDABRAXIS PHARMNDA 0193501987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.4MG COPPER/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (2)
Abbreviated applications
- CUPRIC SULFATEAPOTEX CORPANDA 2187452024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.4MG COPPER/ML INJECTABLE INJECTION Discontinued — - CUPRIC SULFATERSAM REGENTANDA 2163242022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.4MG COPPER/ML INJECTABLE INJECTION Rx —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
39 yr 11 mo ago
Most recent approval
2 yr 1 mo ago
Approvals span 1987–2024 across 3 FDA applications.
Brand (NDA) 133%
Generic (ANDA) 267%
Cupric sulfate: 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 BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
