FDA Orange Book · active-ingredient family
Stavudine
Stavudine is approved as 3 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ZERIT · NDA 020413
3
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, capsule, extended release, for solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZERITRLD | BRISTOL | NDA 020413 | — | Sep 06, 1996 | |
| ZERITRLD×5 | BRISTOL | NDA 020412 | — | Jun 24, 1994 | |
| ZERIT XR×4 | BRISTOL MYERS SQUIBB | NDA 021453 | — | Dec 31, 2002 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| STAVUDINE | CIPLA LTD | ANDA 078030 | — | Mar 20, 2009 | |
| STAVUDINE×2 | PHARMOBEDIENT | ANDA 078775 | — | Jan 05, 2009 | |
| STAVUDINE×4 | AUROBINDO PHARMA | ANDA 077672 | — | Dec 29, 2008 | |
| STAVUDINE×4 | HETERO LABS LTD III | ANDA 078957 | — | Dec 29, 2008 | |
| STAVUDINE×4 | PHARMOBEDIENT | ANDA 079069 | — | Dec 29, 2008 | |
| STAVUDINE | AUROBINDO PHARMA | ANDA 077774 | — | Dec 29, 2008 |
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.
Stavudine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
