Orange Book product · Generic (ANDA)
PACLITAXEL
PACLITAXEL
At a glance
Aug 24, 2020
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 24, 2020
5 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
PACLITAXEL
Strength
6MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 213434
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
- 2025PACLITAXELGeneric (ANDA)
ANDA 209657 · CIPLA
- 2024PACLITAXELGeneric (ANDA)
ANDA 212700 · HENGRUI PHARMA
- 2022PACLITAXELGeneric (ANDA)
ANDA 216874 · ALEMBIC
- 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.
