FDA Orange Book · active-ingredient family
Cisplatin
Cisplatin is approved as 1 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CISPLATIN · NDA 018057
1
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CISPLATINRLD×4 | HQ SPCLT PHARMA | NDA 018057 | AP | Nov 08, 1988 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CISPLATIN | QILU | ANDA 218868 | AP | May 10, 2024 | |
| CISPLATIN | GLAND | ANDA 207323 | AP | Mar 17, 2017 | |
| CISPLATIN | ACCORD HLTHCARE | ANDA 206774 | AP | Aug 18, 2015 | |
| CISPLATIN | PHARMOBEDIENT | ANDA 091062 | — | Apr 18, 2012 | |
| CISPLATIN×2 | BEDFORD | ANDA 074713 | — | Nov 14, 2000 | |
| CISPLATIN | HIKMA | ANDA 075036 | AP | Nov 07, 2000 | |
| CISPLATIN | PHARMACHEMIE BV | ANDA 074656 | AP | May 16, 2000 | |
| CISPLATIN | TEVA PHARMS USA | ANDA 074814 | — | May 16, 2000 | |
| CISPLATIN | FRESENIUS KABI USA | ANDA 074735 | AP | Jul 16, 1999 |
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.
Cisplatin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
