Orange Book product · Brand (NDA)
SURMONTIL
TRIMIPRAMINE MALEATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
TRIMIPRAMINE MALEATE
Strength
EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 016792
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.
- 2016TRIMIPRAMINE MALEATEGeneric (ANDA)
ANDA 208127 · BRECKENRIDGE
- 2006TRIMIPRAMINE MALEATEGeneric (ANDA)
ANDA 077361 · ELITE LABS INC
- 1987TRIMIPRAMINE MALEATEGeneric (ANDA)
ANDA 071283 · USL PHARMA
- 1987TRIMIPRAMINE MALEATEGeneric (ANDA)
ANDA 071284 · USL PHARMA
- 1987TRIMIPRAMINE MALEATEGeneric (ANDA)
ANDA 071285 · USL 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.
