Orange Book product · Brand (NDA)
DOCETAXEL
DOCETAXEL
At a glance
Mar 08, 2011
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 08, 2011
15 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
DOCETAXEL
Strength
80MG/8ML (10MG/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 022234
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2024BEIZRAYBrand (NDA)
NDA 218711 · ZHUHAI
- 2022DOCIVYXBrand (NDA)
NDA 215813 · AVYXA HOLDINGS
- 2015DOCETAXELBrand (NDA)
NDA 205934 · SHILPA
- 2014DOCETAXELBrand (NDA)
NDA 202356 · PFIZER LABS
- 2013DOCETAXELBrand (NDA)
NDA 203551 · ACTAVIS
- 2012DOCETAXELBrand (NDA)
NDA 022312 · APOTEX INC
- 2011DOCETAXELBrand (NDA)
NDA 201525 · SANDOZ
- 2011DOCETAXELBrand (NDA)
NDA 201195 · ACCORD HLTHCARE
- 2011DOCEFREZBrand (NDA)
NDA 022534 · SUN PHARM
- 2010TAXOTEREBrand (NDA)
NDA 020449 · SANOFI AVENTIS US
- 2025DOCETAXELGeneric (ANDA)
ANDA 213768 · GUANGDONG SUNHO
- 2024DOCETAXELGeneric (ANDA)
ANDA 216677 · HERITAGE
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.
