Orange Book product · Generic (ANDA)
ACYCLOVIR
ACYCLOVIR
At a glance
Feb 04, 2019
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 04, 2019
7 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
ACYCLOVIR
Strength
5%
Dosage form
CREAM
Route
TOPICAL
TE code
AB
Application
ANDA 208702
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
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
- 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
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.
