Orange Book product · Generic (ANDA)
PACLITAXEL
PACLITAXEL
At a glance
Apr 10, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 10, 2025
1 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
PACLITAXEL
Strength
100MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
AB
Application
ANDA 209657
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of PACLITAXEL
- 2023PACLITAXELBrand (NDA)
NDA 216338 · TEVA PHARMS INC
- 2022PACLITAXELBrand (NDA)
NDA 211875 · AM REGENT
- 2005ABRAXANEBrand (NDA)
NDA 021660 · BRISTOL-MYERS
- 1992TAXOLBrand (NDA)
NDA 020262 · HQ SPCLT PHARMA
- 2025PACLITAXELGeneric (ANDA)
ANDA 217877 · MYLAN
- 2025PACLITAXELGeneric (ANDA)
ANDA 216355 · SHUANGCHENG
- 2024PACLITAXELGeneric (ANDA)
ANDA 212700 · HENGRUI PHARMA
- 2022PACLITAXELGeneric (ANDA)
ANDA 216874 · ALEMBIC
- 2020PACLITAXELGeneric (ANDA)
ANDA 213434 · MSN
- 2018PACLITAXELGeneric (ANDA)
ANDA 205720 · ACCORD HLTHCARE
- 2016PACLITAXELGeneric (ANDA)
ANDA 207326 · GLAND
- 2011PACLITAXELGeneric (ANDA)
ANDA 091540 · NATCO PHARMA USA
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.
