Orange Book product · Generic (ANDA)
VIVACTIL
PROTRIPTYLINE HYDROCHLORIDE
At a glance
Aug 24, 1995
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 24, 1995
31 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
PROTRIPTYLINE HYDROCHLORIDE
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 073644
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of PROTRIPTYLINE HYDROCHLORIDE
- —VIVACTILBrand (NDA)
NDA 016012 · TEVA WOMENS
- 2012PROTRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 202220 · EPIC PHARMA LLC
- 2010PROTRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 090462 · SIGMAPHARM LABS LLC
- 2008PROTRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 078913 · HIKMA
- 1995VIVACTILGeneric (ANDA)
ANDA 073645 · CHARTWELL RX
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.
