FDA Orange Book · active-ingredient family
Carboplatin
Carboplatin: 3 brands, 34 generics; first approved Mar 03, 1989; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 34 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
3
Generics (ANDA)
34
Listed patents
1
Next patent expiry
Apr 01, 2045
in 18 yr 11 mo
Brand (NDA) products
Originator applications
- KYXATARLDAVYXA HOLDINGSNDA 21992120253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/2ML (10MG/ML) SOLUTION INTRAVENOUS Discontinued — 80MG/8ML (10MG/ML) SOLUTION INTRAVENOUS Rx — 500MG/50ML (10MG/ML) SOLUTION INTRAVENOUS Rx — - PARAPLATINRLDCORDENPHARMANDA 02045220034 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 150MG/15ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 450MG/45ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 600MG/60ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — - PARAPLATINRLDCORDEN PHARMANDA 01988019893 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INJECTION Discontinued — 150MG/VIAL INJECTABLE INJECTION Discontinued — 450MG/VIAL INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (34)
Abbreviated applications
- CARBOPLATINQILU PHARM HAINANANDA 21999920264 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 150MG/15ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 450MG/45ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 600MG/60ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP - CARBOPLATINRSACCORD HLTHCAREANDA 20677520205 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 150MG/15ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 450MG/45ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 600MG/60ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 1GM/100ML (10MG/ML) INJECTABLE INTRAVENOUS Rx — - CARBOPLATININGENUS PHARMS LLCANDA 20848720174 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 150MG/15ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 450MG/45ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 600MG/60ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — - CARBOPLATINGLANDANDA 20732420174 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 150MG/15ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 450MG/45ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 600MG/60ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP - CARBOPLATINEUGIA PHARMAANDA 20548720164 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 150MG/15ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 450MG/45ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 600MG/60ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP - CARBOPLATINNATCO PHARMA USAANDA 09151020123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INJECTION Discontinued — 150MG/VIAL INJECTABLE INJECTION Discontinued — 450MG/VIAL INJECTABLE INJECTION Discontinued — - CARBOPLATINACTAVIS TOTOWAANDA 07873220124 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 150MG/15ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 450MG/45ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 600MG/60ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — - CARBOPLATINPHARMOBEDIENTANDA 0914782011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/100ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — - CARBOPLATINPHARMOBEDIENTANDA 09106320114 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 150MG/15ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 450MG/45ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 600MG/60ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — - CARBOPLATINEPIC PHARMA LLCANDA 0912682010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG/60ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP - CARBOPLATINEPIC PHARMA LLCANDA 09047520093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 150MG/15ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 450MG/45ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP - CARBOPLATINPHARMACHEMIE BVANDA 07767920093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 150MG/15ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 450MG/45ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — - CARBOPLATINPLIVA LACHEMAANDA 07863120084 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 150MG/15ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 450MG/45ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 600MG/60ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — - CARBOPLATINSUN PHARMANDA 07792620083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 150MG/15ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 450MG/45ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP - CARBOPLATINSANDOZANDA 07828020083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 150MG/15ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 450MG/45ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP - CARBOPLATINPHARMOBEDIENTANDA 07799820073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 150MG/15ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 450MG/45ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — - CARBOPLATINTEVA PARENTERALANDA 07738920073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 150MG/15ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 450MG/45ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — - CARBOPLATINTEYRO LABSANDA 07786120074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 150MG/15ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 450MG/45ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 600MG/60ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP - CARBOPLATINFRESENIUS KABI USAANDA 07743220063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 150MG/15ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 450MG/45ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — - CARBOPLATINFRESENIUS KABI USAANDA 07726620064 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 150MG/15ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 450MG/45ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 600MG/60ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP - CARBOPLATINCIPLA LTDANDA 07738320063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INJECTION Discontinued — 150MG/VIAL INJECTABLE INJECTION Discontinued — 450MG/VIAL INJECTABLE INJECTION Discontinued — - CARBOPLATINTEVA PHARMS USAANDA 07713920054 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 150MG/15ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 450MG/45ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 600MG/60ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — - CARBOPLATINMEITHEALANDA 07709620054 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 150MG/15ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 450MG/45ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 600MG/60ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — - CARBOPLATINSANDOZANDA 07695920053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INJECTION Discontinued — 150MG/VIAL INJECTABLE INJECTION Discontinued — 450MG/VIAL INJECTABLE INJECTION Discontinued — - CARBOPLATINRSHOSPIRAANDA 0770592004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG/60ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP - CARBOPLATINPLIVAANDA 07660220043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INJECTION Discontinued — 150MG/VIAL INJECTABLE INJECTION Discontinued — 450MG/VIAL INJECTABLE INJECTION Discontinued — - CARBOPLATINHOSPIRAANDA 07647320043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INJECTION Discontinued — 150MG/VIAL INJECTABLE INJECTION Discontinued — 450MG/VIAL INJECTABLE INJECTION Discontinued — - CARBOPLATINFRESENIUS KABI USAANDA 07724720043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 150MG/15ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — 450MG/45ML (10MG/ML) INJECTABLE INTRAVENOUS Discontinued — - CARBOPLATINHIKMAANDA 07724420044 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 150MG/15ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 450MG/45ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 600MG/60ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP - CARBOPLATINFRESENIUS KABI USAANDA 07623520043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INJECTION Discontinued — 150MG/VIAL INJECTABLE INJECTION Discontinued — 450MG/VIAL INJECTABLE INJECTION Discontinued — - CARBOPLATINHIKMAANDA 07609920043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INJECTION Discontinued — 150MG/VIAL INJECTABLE INJECTION Discontinued — 450MG/VIAL INJECTABLE INJECTION Discontinued — - CARBOPLATINWATSON LABS TEVAANDA 07616220043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INJECTION Discontinued — 150MG/VIAL INJECTABLE INJECTION Discontinued — 450MG/VIAL INJECTABLE INJECTION Discontinued — - CARBOPLATINRSHOSPIRAANDA 07651720043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 150MG/15ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 450MG/45ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP - CARBOPLATINPHARMACHEMIE BVANDA 07726920044 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 150MG/15ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 450MG/45ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 600MG/60ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 12427104 | in 18 yr 11 mo | Product |
Approval history
FDA approval span
First approval
38 yr ago
Most recent approval
7 mo ago
Approvals span 1989–2026 across 37 FDA applications.
Brand (NDA) 38%
Generic (ANDA) 3492%
Carboplatin: 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.
