Orange Book product · Generic (ANDA)
GANCICLOVIR SODIUM
GANCICLOVIR SODIUM
At a glance
Nov 08, 2018
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 08, 2018
7 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
GANCICLOVIR SODIUM
Strength
EQ 500MG BASE/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 204204
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of GANCICLOVIR SODIUM
- 1989CYTOVENEBrand (NDA)
NDA 019661 · CHEPLAPHARM
- 2019GANCICLOVIR SODIUMGeneric (ANDA)
ANDA 212001 · CUSTOPHARM INC
- 2017GANCICLOVIR SODIUMGeneric (ANDA)
ANDA 207645 · PHARMASCIENCE INC
- 2017GANCICLOVIR SODIUMGeneric (ANDA)
ANDA 204560 · ONESOURCE SPECIALTY
- 2016GANCICLOVIR SODIUMGeneric (ANDA)
ANDA 204950 · PH HEALTH
- 2013GANCICLOVIR SODIUMGeneric (ANDA)
ANDA 202624 · AM REGENT
- 2010GANCICLOVIR SODIUMGeneric (ANDA)
ANDA 090658 · FRESENIUS KABI USA
- 2003GANCICLOVIR SODIUMGeneric (ANDA)
ANDA 076222 · HIKMA
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.
