Orange Book product · Brand (NDA)
ZERIT XR
STAVUDINE
At a glance
Dec 31, 2002
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 31, 2002
23 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
STAVUDINE
Strength
37.5MG
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 021453
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 1996ZERITBrand (NDA)
NDA 020413 · BRISTOL
- 1994ZERITBrand (NDA)
NDA 020412 · BRISTOL
- 2009STAVUDINEGeneric (ANDA)
ANDA 078030 · CIPLA LTD
- 2009STAVUDINEGeneric (ANDA)
ANDA 078775 · PHARMOBEDIENT
- 2008STAVUDINEGeneric (ANDA)
ANDA 077672 · AUROBINDO PHARMA
- 2008STAVUDINEGeneric (ANDA)
ANDA 078957 · HETERO LABS LTD III
- 2008STAVUDINEGeneric (ANDA)
ANDA 079069 · PHARMOBEDIENT
- 2008STAVUDINEGeneric (ANDA)
ANDA 077774 · AUROBINDO PHARMA
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.
