Orange Book product · Brand (NDA)
ZOVIRAX
ACYCLOVIR SODIUM
At a glance
Aug 30, 1983
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 30, 1983
43 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
ACYCLOVIR SODIUM
Strength
EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 018603
Product number
003
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.
- 2024ACYCLOVIR SODIUMGeneric (ANDA)
ANDA 215404 · FRESENIUS KABI USA
- 2024ACYCLOVIR SODIUMGeneric (ANDA)
ANDA 218111 · SLATE RUN PHARMA
- 2020ACYCLOVIR SODIUMGeneric (ANDA)
ANDA 207919 · DR REDDYS
- 2018ACYCLOVIR SODIUMGeneric (ANDA)
ANDA 206535 · ZYDUS PHARMS
- 2017ACYCLOVIR SODIUMGeneric (ANDA)
ANDA 206606 · ZYDUS PHARMS
- 2017ACYCLOVIR SODIUMGeneric (ANDA)
ANDA 203927 · PHARMOBEDIENT
- 2016ACYCLOVIR SODIUMGeneric (ANDA)
ANDA 205771 · HIKMA
- 2013ACYCLOVIR SODIUMGeneric (ANDA)
ANDA 203701 · EUGIA PHARMA
- 2001ACYCLOVIR SODIUMGeneric (ANDA)
ANDA 075627 · TEVA PARENTERAL
- 1999ACYCLOVIRGeneric (ANDA)
ANDA 075114 · ABBVIE
- 1999ACYCLOVIR SODIUMGeneric (ANDA)
ANDA 075065 · HOSPIRA
- 1998ACYCLOVIR SODIUMGeneric (ANDA)
ANDA 074930 · 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.
