Orange Book product · Brand (NDA)
ZOVIRAX
ACYCLOVIR
At a glance
Dec 30, 2002
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 30, 2002
23 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
ACYCLOVIR
Strength
5%
Dosage form
CREAM
Route
TOPICAL
TE code
AB
Application
NDA 021478
Product number
001
Marketing status
RX
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
- 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 215669 · HETERO LABS LTD III
- 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.
