Orange Book product · Brand (NDA)
TAXOL
PACLITAXEL
At a glance
Dec 29, 1992
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 29, 1992
34 yr ago
Today
Pharmaceutical detail
Active ingredient
PACLITAXEL
Strength
6MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 020262
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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
- 2022PACLITAXELBrand (NDA)
NDA 211875 · AM REGENT
- 2005ABRAXANEBrand (NDA)
NDA 021660 · BRISTOL-MYERS
- 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.
