Orange Book product · Brand (NDA)
CYTOVENE
GANCICLOVIR SODIUM
At a glance
Jun 23, 1989
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 23, 1989
37 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
GANCICLOVIR SODIUM
Strength
EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 019661
Product number
001
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.
- 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
- 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.
