Orange Book product · Brand (NDA)
MAVIK
TRANDOLAPRIL
At a glance
Apr 26, 1996
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 26, 1996
30 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
TRANDOLAPRIL
Strength
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 020528
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.
- 2008TRANDOLAPRILGeneric (ANDA)
ANDA 078493 · SENORES PHARMS
- 2008TRANDOLAPRILGeneric (ANDA)
ANDA 078508 · EPIC PHARMA
- 2008TRANDOLAPRILGeneric (ANDA)
ANDA 078346 · PHARMOBEDIENT
- 2007TRANDOLAPRILGeneric (ANDA)
ANDA 078438 · AUROBINDO PHARMA
- 2007TRANDOLAPRILGeneric (ANDA)
ANDA 077307 · CHARTWELL MOLECULAR
- 2007TRANDOLAPRILGeneric (ANDA)
ANDA 077256 · EPIC PHARMA LLC
- 2007TRANDOLAPRILGeneric (ANDA)
ANDA 078320 · INVAGEN PHARMS
- 2007TRANDOLAPRILGeneric (ANDA)
ANDA 077522 · LUPIN
- 2007TRANDOLAPRILGeneric (ANDA)
ANDA 077805 · WATSON LABS
- 2006TRANDOLAPRILGeneric (ANDA)
ANDA 077489 · TEVA PHARMS
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.
