Orange Book product · Brand (NDA)
VIRAMUNE XR
NEVIRAPINE
At a glance
Nov 08, 2012
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 08, 2012
13 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
NEVIRAPINE
Strength
100MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 201152
Product number
002
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.
- 1998VIRAMUNEBrand (NDA)
NDA 020933 · BOEHRINGER INGELHEIM
- 1996VIRAMUNEBrand (NDA)
NDA 020636 · BOEHRINGER INGELHEIM
- 2019NEVIRAPINEGeneric (ANDA)
ANDA 090688 · MACLEODS PHARMS LTD
- 2017NEVIRAPINEGeneric (ANDA)
ANDA 206879 · MACLEODS PHARMS LTD
- 2017NEVIRAPINEGeneric (ANDA)
ANDA 207684 · CIPLA
- 2017NEVIRAPINEGeneric (ANDA)
ANDA 207467 · TECH ORGANIZED
- 2017NEVIRAPINEGeneric (ANDA)
ANDA 207698 · AUROBINDO PHARMA
- 2016NEVIRAPINEGeneric (ANDA)
ANDA 208616 · AUROBINDO PHARMA
- 2015NEVIRAPINEGeneric (ANDA)
ANDA 204621 · ALVOGEN
- 2015NEVIRAPINEGeneric (ANDA)
ANDA 206271 · PHARMOBEDIENT
- 2015NEVIRAPINEGeneric (ANDA)
ANDA 206448 · CIPLA
- 2014NEVIRAPINEGeneric (ANDA)
ANDA 205651 · MYLAN
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.
