Orange Book product · Brand (NDA)
PARAPLATIN
CARBOPLATIN
At a glance
Jul 14, 2003
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 14, 2003
23 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
CARBOPLATIN
Strength
150MG/15ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 020452
Product number
002
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.
- 2025KYXATABrand (NDA)
NDA 219921 · AVYXA HOLDINGS
- 1989PARAPLATINBrand (NDA)
NDA 019880 · CORDEN PHARMA
- 2026CARBOPLATINGeneric (ANDA)
ANDA 219999 · QILU PHARM HAINAN
- 2020CARBOPLATINGeneric (ANDA)
ANDA 206775 · ACCORD HLTHCARE
- 2017CARBOPLATINGeneric (ANDA)
ANDA 208487 · INGENUS PHARMS LLC
- 2017CARBOPLATINGeneric (ANDA)
ANDA 207324 · GLAND
- 2016CARBOPLATINGeneric (ANDA)
ANDA 205487 · EUGIA PHARMA
- 2012CARBOPLATINGeneric (ANDA)
ANDA 091510 · NATCO PHARMA USA
- 2012CARBOPLATINGeneric (ANDA)
ANDA 078732 · ACTAVIS TOTOWA
- 2011CARBOPLATINGeneric (ANDA)
ANDA 091478 · PHARMOBEDIENT
- 2011CARBOPLATINGeneric (ANDA)
ANDA 091063 · PHARMOBEDIENT
- 2010CARBOPLATINGeneric (ANDA)
ANDA 091268 · EPIC PHARMA LLC
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.
