Orange Book product · Generic (ANDA)
DOCETAXEL
DOCETAXEL
At a glance
Jan 19, 2018
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 19, 2018
8 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
DOCETAXEL
Strength
20MG/ML (20MG/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 209640
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of DOCETAXEL
- 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
- 2011DOCETAXELBrand (NDA)
NDA 022234 · HOSPIRA INC
- 2010TAXOTEREBrand (NDA)
NDA 020449 · SANOFI AVENTIS US
- 2025DOCETAXELGeneric (ANDA)
ANDA 213768 · GUANGDONG SUNHO
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.
