Orange Book product · Generic (ANDA)
GANCICLOVIR SODIUM
GANCICLOVIR SODIUM
At a glance
Jul 16, 2003
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 16, 2003
23 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
GANCICLOVIR SODIUM
Strength
EQ 500MG BASE/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 076222
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
- 2018GANCICLOVIR SODIUMGeneric (ANDA)
ANDA 204204 · SLATE RUN PHARMA
- 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
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.
