Orange Book product · Generic (ANDA)
THIOTEPA
THIOTEPA
At a glance
Dec 26, 2023
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 26, 2023
2 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
THIOTEPA
Strength
15MG/VIAL
Dosage form
POWDER
Route
INTRACAVITARY, INTRAVENOUS, INTRAVESICAL
TE code
AP
Application
ANDA 216037
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of THIOTEPA
- 2024TEPYLUTEBrand (NDA)
NDA 216984 · SHORLA
- 2017TEPADINABrand (NDA)
NDA 208264 · ADIENNE SA
- 1994THIOPLEXBrand (NDA)
NDA 020058 · IMMUNEX
- —THIOTEPABrand (NDA)
NDA 011683 · IMMUNEX
- 2024THIOTEPAGeneric (ANDA)
ANDA 217559 · REGCON HOLDINGS
- 2023THIOTEPAGeneric (ANDA)
ANDA 211755 · HIKMA
- 2021THIOTEPAGeneric (ANDA)
ANDA 211831 · REGCON HOLDINGS
- 2021THIOTEPAGeneric (ANDA)
ANDA 214222 · GLAND
- 2020THIOTEPAGeneric (ANDA)
ANDA 213049 · MSN
- 2020THIOTEPAGeneric (ANDA)
ANDA 208242 · PENN LIFE
- 2018THIOTEPAGeneric (ANDA)
ANDA 210337 · DR REDDYS
- 2018THIOTEPAGeneric (ANDA)
ANDA 209150 · HENGRUI PHARMA
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.
