Orange Book product · Brand (NDA)
TEPADINA
THIOTEPA
At a glance
Jan 26, 2017
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 26, 2017
9 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
THIOTEPA
Strength
100MG/VIAL
Dosage form
POWDER
Route
INTRACAVITARY, INTRAVENOUS, INTRAVESICAL
TE code
AP
Application
NDA 208264
Product number
002
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.
- 2024TEPYLUTEBrand (NDA)
NDA 216984 · SHORLA
- 1994THIOPLEXBrand (NDA)
NDA 020058 · IMMUNEX
- —THIOTEPABrand (NDA)
NDA 011683 · IMMUNEX
- 2024THIOTEPAGeneric (ANDA)
ANDA 217559 · REGCON HOLDINGS
- 2023THIOTEPAGeneric (ANDA)
ANDA 216037 · MEITHEAL
- 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.
