Orange Book product · Brand (NDA)
THIOPLEX
THIOTEPA
At a glance
Dec 22, 1994
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 22, 1994
31 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
THIOTEPA
Strength
15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 020058
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.
- 2024TEPYLUTEBrand (NDA)
NDA 216984 · SHORLA
- 2017TEPADINABrand (NDA)
NDA 208264 · ADIENNE SA
- —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.
