Orange Book product · Generic (ANDA)
PACLITAXEL
PACLITAXEL
At a glance
Jan 25, 2002
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 25, 2002
24 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
PACLITAXEL
Strength
6MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 075184
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
- 2020PACLITAXELGeneric (ANDA)
ANDA 213434 · MSN
- 2018PACLITAXELGeneric (ANDA)
ANDA 205720 · ACCORD HLTHCARE
- 2016PACLITAXELGeneric (ANDA)
ANDA 207326 · GLAND
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.
