Orange Book product · Generic (ANDA)
IRINOTECAN HYDROCHLORIDE
IRINOTECAN HYDROCHLORIDE
At a glance
Nov 02, 2020
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 02, 2020
5 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
IRINOTECAN HYDROCHLORIDE
Strength
40MG/2ML (20MG/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 213278
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of IRINOTECAN HYDROCHLORIDE
- 2015ONIVYDEBrand (NDA)
NDA 207793 · IPSEN
- 1996CAMPTOSARBrand (NDA)
NDA 020571 · PFIZER INC
- 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.
