Orange Book product · Generic (ANDA)
ACYCLOVIR
ACYCLOVIR
At a glance
May 02, 2025
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 02, 2025
1 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
ACYCLOVIR
Strength
5%
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
ANDA 212981
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ACYCLOVIR
- 2019AVACLYRBrand (NDA)
NDA 202408 · FERA PHARMS LLC
- 2002ZOVIRAXBrand (NDA)
NDA 021478 · BAUSCH
- 1985ZOVIRAXBrand (NDA)
NDA 018828 · PHARMOBEDIENT
- 1982ZOVIRAXBrand (NDA)
NDA 018604 · BAUSCH
- 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.
