Orange Book product · Brand (NDA)
VIRAMUNE
NEVIRAPINE
At a glance
Sep 11, 1998
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 11, 1998
28 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
NEVIRAPINE
Strength
50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 020933
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.
- 2012VIRAMUNE XRBrand (NDA)
NDA 201152 · 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.
