Orange Book product · Brand (NDA)
DEMADEX
TORSEMIDE
At a glance
Aug 23, 1993
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 23, 1993
33 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
TORSEMIDE
Strength
50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 020137
Product number
002
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.
- 2021SOAANZBrand (NDA)
NDA 213218 · SARFE PHARMS
- 1993DEMADEXBrand (NDA)
NDA 020136 · PHARMOBEDIENT
- 2026TORSEMIDEGeneric (ANDA)
ANDA 217239 · MICRO LABS
- 2011TORSEMIDEGeneric (ANDA)
ANDA 090613 · STRIDES PHARMA INTL
- 2010TORSEMIDEGeneric (ANDA)
ANDA 090656 · AM REGENT
- 2009TORSEMIDEGeneric (ANDA)
ANDA 079234 · HETERO LABS LTD III
- 2008TORSEMIDEGeneric (ANDA)
ANDA 078007 · HIKMA
- 2008TORSEMIDEGeneric (ANDA)
ANDA 078478 · SUN PHARM INDS
- 2007TORSEMIDEGeneric (ANDA)
ANDA 078249 · AUROBINDO PHARMA
- 2005TORSEMIDEGeneric (ANDA)
ANDA 076894 · COREPHARMA
- 2005TORSEMIDEGeneric (ANDA)
ANDA 076943 · HIKMA
- 2003TORSEMIDEGeneric (ANDA)
ANDA 076346 · PLIVA PHARM IND
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.
