Orange Book product · Generic (ANDA)
ACYCLOVIR
ACYCLOVIR
At a glance
Apr 22, 1997
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 22, 1997
29 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
ACYCLOVIR
Strength
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 074556
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)
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- 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.
