Orange Book product · Generic (ANDA)
GRANISETRON HYDROCHLORIDE
GRANISETRON HYDROCHLORIDE
At a glance
Dec 31, 2007
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 31, 2007
18 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
GRANISETRON HYDROCHLORIDE
Strength
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 078392
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of GRANISETRON HYDROCHLORIDE
- 2004KYTRILBrand (NDA)
NDA 020239 · ROCHE
- 2001KYTRILBrand (NDA)
NDA 021238 · ROCHE
- 1995KYTRILBrand (NDA)
NDA 020305 · ROCHE
- 2025GRANISETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 219282 · INTRA SANA LABS
- 2020GRANISETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 202648 · YUNG SHIN PHARM
- 2020GRANISETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 202647 · YUNG SHIN PHARM
- 2017GRANISETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 203454 · PHARMOBEDIENT
- 2017GRANISETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 203453 · PHARMOBEDIENT
- 2016GRANISETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 204238 · EUGIA PHARMA
- 2010GRANISETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 091274 · AM REGENT
- 2010GRANISETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 090817 · TARO
- 2010GRANISETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 091136 · MYLAN ASI
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.
