Orange Book product · Brand (NDA)
AVACLYR
ACYCLOVIR
At a glance
Mar 29, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 29, 2019
7 yr 4 mo ago
Exclusivity ends · ODE-235
Orphan-drug exclusivity (7 years)
Mar 29, 2026
3 mo ago
Today
Pharmaceutical detail
Active ingredient
ACYCLOVIR
Strength
3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
OINTMENT
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 202408
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.
- 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
- 2020ACYCLOVIRGeneric (ANDA)
ANDA 208766 · AMNEAL
Marketing exclusivity (1)
- ODE-235Orphan-drug exclusivity (7 years)
Mar 29, 2026
3 mo ago
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.
