Orange Book product · Generic (ANDA)
FAMCICLOVIR
FAMCICLOVIR
At a glance
Sep 10, 2014
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 10, 2014
11 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
FAMCICLOVIR
Strength
125MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 202438
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FAMCICLOVIR
- 1995FAMVIRBrand (NDA)
NDA 020363 · NOVARTIS
- 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.
