Orange Book product · Brand (NDA)
ZOVIRAX
ACYCLOVIR
At a glance
Dec 22, 1989
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 22, 1989
37 yr ago
Today
Pharmaceutical detail
Active ingredient
ACYCLOVIR
Strength
200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 019909
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.
- 2019AVACLYRBrand (NDA)
NDA 202408 · FERA PHARMS LLC
- 2002ZOVIRAXBrand (NDA)
NDA 021478 · BAUSCH
- 1985ZOVIRAXBrand (NDA)
NDA 018828 · PHARMOBEDIENT
- 1982ZOVIRAXBrand (NDA)
NDA 018604 · BAUSCH
- 2025ACYCLOVIRGeneric (ANDA)
ANDA 212981 · CIPLA
- 2024ACYCLOVIRGeneric (ANDA)
ANDA 205470 · SUN PHARMA CANADA
- 2023ACYCLOVIRGeneric (ANDA)
ANDA 212361 · ALEMBIC
- 2023ACYCLOVIRGeneric (ANDA)
ANDA 206770 · ZYDUS LIFESCIENCES
- 2022ACYCLOVIRGeneric (ANDA)
ANDA 216331 · AUROBINDO PHARMA
- 2021ACYCLOVIRGeneric (ANDA)
ANDA 212202 · PRINSTON INC
- 2021ACYCLOVIRGeneric (ANDA)
ANDA 212444 · MACLEODS PHARMS LTD
- 2020ACYCLOVIRGeneric (ANDA)
ANDA 208766 · AMNEAL
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.
