Orange Book product · Brand (NDA)
FAMVIR
FAMCICLOVIR
At a glance
Dec 11, 1995
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 11, 1995
31 yr ago
Today
Pharmaceutical detail
Active ingredient
FAMCICLOVIR
Strength
125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
NDA 020363
Product number
003
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.
- 2014FAMCICLOVIRGeneric (ANDA)
ANDA 202438 · HETERO LABS LTD V
- 2012FAMCICLOVIRGeneric (ANDA)
ANDA 201022 · MACLEODS PHARMS LTD
- 2011FAMCICLOVIRGeneric (ANDA)
ANDA 091480 · APOTEX
- 2011FAMCICLOVIRGeneric (ANDA)
ANDA 201333 · NATCO PHARMA
- 2011FAMCICLOVIRGeneric (ANDA)
ANDA 091114 · AUROBINDO PHARMA LTD
- 2011FAMCICLOVIRGeneric (ANDA)
ANDA 078278 · CIPLA
- 2011FAMCICLOVIRGeneric (ANDA)
ANDA 090128 · HIKMA
- 2007FAMCICLOVIRGeneric (ANDA)
ANDA 077487 · TEVA PHARMS
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.
