Orange Book product · Brand (NDA)
PLATINOL-AQ
CISPLATIN
At a glance
Jul 18, 1984
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 18, 1984
42 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
CISPLATIN
Strength
0.5MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 018057
Product number
003
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.
