Orange Book product · Brand (NDA)
ZERIT
STAVUDINE
At a glance
Jun 24, 1994
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 24, 1994
32 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
STAVUDINE
Strength
40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 020412
Product number
005
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.
- 2002ZERIT XRBrand (NDA)
NDA 021453 · BRISTOL MYERS SQUIBB
- 1996ZERITBrand (NDA)
NDA 020413 · 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.
