Orange Book product · Brand (NDA)
ZOFRAN ODT
ONDANSETRON
At a glance
Jan 27, 1999
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 27, 1999
27 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
ONDANSETRON
Strength
4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
TE code
Not listed
Application
NDA 020781
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.
- 2010ZUPLENZBrand (NDA)
NDA 022524 · AQUESTIVE
- 2023ONDANSETRONGeneric (ANDA)
ANDA 209389 · IPCA LABS LTD
- 2011ONDANSETRONGeneric (ANDA)
ANDA 078602 · SUN PHARM INDS LTD
- 2010ONDANSETRONGeneric (ANDA)
ANDA 090469 · AUROBINDO PHARMA
- 2007ONDANSETRONGeneric (ANDA)
ANDA 078050 · SANDOZ
- 2007ONDANSETRONGeneric (ANDA)
ANDA 077557 · SUN PHARM INDS
- 2007ONDANSETRONGeneric (ANDA)
ANDA 078152 · GLENMARK PHARMS LTD
- 2007ONDANSETRONGeneric (ANDA)
ANDA 076693 · BARR
- 2007ONDANSETRONGeneric (ANDA)
ANDA 077717 · NESHER PHARMS
- 2007ONDANSETRONGeneric (ANDA)
ANDA 078139 · PHARMOBEDIENT
- 2007ONDANSETRONGeneric (ANDA)
ANDA 076810 · TEVA
- 2006ONDANSETRONGeneric (ANDA)
ANDA 077406 · CHARTWELL MOLECULES
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.
