Orange Book product · Generic (ANDA)
TREPROSTINIL
TREPROSTINIL
At a glance
Sep 26, 2019
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 26, 2019
6 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
TREPROSTINIL
Strength
1MG/ML
Dosage form
INJECTABLE
Route
INTRAVENOUS, SUBCUTANEOUS
TE code
AP
Application
ANDA 206648
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of TREPROSTINIL
- 2023REMODULINBrand (NDA)
NDA 021272 · UNITED THERAP
- 2022TYVASO DPIBrand (NDA)
NDA 214324 · UNITED THERAP
- 2018REMODULINBrand (NDA)
NDA 208276 · UNITED THERAP
- 2009TYVASOBrand (NDA)
NDA 022387 · UNITED THERAP
- 2021TREPROSTINILGeneric (ANDA)
ANDA 211574 · ALEMBIC GLOBAL
- 2020TREPROSTINILGeneric (ANDA)
ANDA 210214 · DR REDDYS
- 2019TREPROSTINILGeneric (ANDA)
ANDA 209382 · PH HEALTH
- 2017TREPROSTINILGeneric (ANDA)
ANDA 203649 · SANDOZ
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.
