Orange Book product · Brand (NDA)
ZOFRAN
ONDANSETRON HYDROCHLORIDE
At a glance
Jan 24, 1997
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 24, 1997
29 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
ONDANSETRON HYDROCHLORIDE
Strength
EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 020605
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.
- 1995ZOFRAN AND DEXTROSE IN PLASTIC CONTAINERBrand (NDA)
NDA 020403 · GLAXOSMITHKLINE
- 1991ZOFRANBrand (NDA)
NDA 020007 · SANDOZ
- 2017ONDANSETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 204906 · RISING
- 2016ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEGeneric (ANDA)
ANDA 206845 · ACCORD HLTHCARE
- 2015ONDANSETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 206846 · ACCORD HLTHCARE
- 2014ONDANSETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 203711 · QILU PHARM HAINAN
- 2013ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEGeneric (ANDA)
ANDA 202253 · FRESENIUS KABI USA
- 2013ONDANSETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 078288 · BAXTER HLTHCARE CORP
- 2013ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEGeneric (ANDA)
ANDA 078287 · BAXTER HLTHCARE CORP
- 2013ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEGeneric (ANDA)
ANDA 078945 · AVET LIFESCIENCES
- 2012ONDANSETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 202599 · EUGIA PHARMA
- 2012ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEGeneric (ANDA)
ANDA 202600 · EUGIA 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.
