Orange Book product · Brand (NDA)
PACLITAXEL
PACLITAXEL
At a glance
Jul 27, 2022
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 27, 2022
3 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
PACLITAXEL
Strength
100MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
AB
Application
NDA 211875
Product number
001
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.
- 2023PACLITAXELBrand (NDA)
NDA 216338 · TEVA PHARMS INC
- 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
- 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.
