FDA Orange Book · active-ingredient family
Cisplatin
Cisplatin: 1 brand, 9 generics; first approved Jul 18, 1984; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 9 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
9
Listed patents
0
Presentations
14
Brand (NDA) products
Originator applications
- CISPLATINRLDHQ SPCLT PHARMANDA 01805719884 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/VIAL INJECTABLE INJECTION Discontinued — 50MG/VIAL INJECTABLE INJECTION Rx — 0.5MG/ML INJECTABLE INJECTION Discontinued — 1MG/ML INJECTABLE INJECTION Rx AP
Generic (ANDA) products (9)
Abbreviated applications
- CISPLATINQILUANDA 2188682024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - CISPLATINGLANDANDA 2073232017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - CISPLATINACCORD HLTHCAREANDA 2067742015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - CISPLATINPHARMOBEDIENTANDA 0910622012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - CISPLATINBEDFORDANDA 07471320002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/VIAL INJECTABLE INJECTION Discontinued — 50MG/VIAL INJECTABLE INJECTION Discontinued — - CISPLATINHIKMAANDA 0750362000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - CISPLATINPHARMACHEMIE BVANDA 0746562000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - CISPLATINTEVA PHARMS USAANDA 0748142000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - CISPLATINRSFRESENIUS KABI USAANDA 0747351999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP
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
42 yr 8 mo ago
Most recent approval
2 yr 4 mo ago
Approvals span 1984–2024 across 10 FDA applications.
Brand (NDA) 110%
Generic (ANDA) 990%
Cisplatin: 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.
