Orange Book product · Brand (NDA)
KYTRIL
GRANISETRON HYDROCHLORIDE
At a glance
Mar 11, 1994
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 11, 1994
32 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
GRANISETRON HYDROCHLORIDE
Strength
EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 020239
Product number
004
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.
- 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
- 2010GRANISETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 091137 · 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.
