Orange Book product · Brand (NDA)
PLATINOL
CISPLATIN
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
CISPLATIN
Strength
10MG/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 018057
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2024CISPLATINGeneric (ANDA)
ANDA 218868 · QILU
- 2017CISPLATINGeneric (ANDA)
ANDA 207323 · GLAND
- 2015CISPLATINGeneric (ANDA)
ANDA 206774 · ACCORD HLTHCARE
- 2012CISPLATINGeneric (ANDA)
ANDA 091062 · PHARMOBEDIENT
- 2000CISPLATINGeneric (ANDA)
ANDA 074713 · BEDFORD
- 2000CISPLATINGeneric (ANDA)
ANDA 075036 · HIKMA
- 2000CISPLATINGeneric (ANDA)
ANDA 074656 · PHARMACHEMIE BV
- 2000CISPLATINGeneric (ANDA)
ANDA 074814 · TEVA PHARMS USA
- 1999CISPLATINGeneric (ANDA)
ANDA 074735 · FRESENIUS KABI USA
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.
