Orange Book product · Brand (NDA)
CAMPTOSAR
IRINOTECAN HYDROCHLORIDE
At a glance
Jun 14, 1996
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 14, 1996
30 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
IRINOTECAN HYDROCHLORIDE
Strength
100MG/5ML (20MG/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 020571
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2015ONIVYDEBrand (NDA)
NDA 207793 · IPSEN
- 2020IRINOTECAN HYDROCHLORIDEGeneric (ANDA)
ANDA 213278 · EUGIA PHARMA
- 2019IRINOTECAN HYDROCHLORIDEGeneric (ANDA)
ANDA 212993 · GLAND
- 2018IRINOTECAN HYDROCHLORIDEGeneric (ANDA)
ANDA 208718 · SHILPA
- 2017IRINOTECAN HYDROCHLORIDEGeneric (ANDA)
ANDA 203054 · INTAS PHARMS USA
- 2017IRINOTECAN HYDROCHLORIDEGeneric (ANDA)
ANDA 206935 · INGENUS PHARMS LLC
- 2016IRINOTECAN HYDROCHLORIDEGeneric (ANDA)
ANDA 203380 · QILU PHARM HAINAN
- 2012IRINOTECAN HYDROCHLORIDEGeneric (ANDA)
ANDA 200771 · EMCURE PHARMS LTD
- 2011IRINOTECAN HYDROCHLORIDEGeneric (ANDA)
ANDA 090675 · HENGRUI PHARMA
- 2011IRINOTECAN HYDROCHLORIDEGeneric (ANDA)
ANDA 090393 · PHARMOBEDIENT
- 2010IRINOTECAN HYDROCHLORIDEGeneric (ANDA)
ANDA 091032 · HIKMA FARMACEUTICA
- 2010IRINOTECAN HYDROCHLORIDEGeneric (ANDA)
ANDA 078953 · CHARTWELL RX
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.
