Orange Book product · Generic (ANDA)
ONDANSETRON
ONDANSETRON
At a glance
Aug 13, 2007
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 13, 2007
19 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
ONDANSETRON
Strength
4MG
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
TE code
AB
Application
ANDA 078050
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ONDANSETRON
- 2010ZUPLENZBrand (NDA)
NDA 022524 · AQUESTIVE
- 1999ZOFRAN ODTBrand (NDA)
NDA 020781 · SANDOZ
- 2023ONDANSETRONGeneric (ANDA)
ANDA 209389 · IPCA LABS LTD
- 2011ONDANSETRONGeneric (ANDA)
ANDA 078602 · SUN PHARM INDS LTD
- 2010ONDANSETRONGeneric (ANDA)
ANDA 090469 · AUROBINDO PHARMA
- 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.
