Orange Book product · Generic (ANDA)
THIOTEPA
THIOTEPA
At a glance
Apr 20, 2001
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 20, 2001
25 yr 6 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15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
ANDA 075730
Product number
001
Marketing status
DISCN
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 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
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.
