Orange Book product · Brand (NDA)
PAMELOR
NORTRIPTYLINE HYDROCHLORIDE
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
NORTRIPTYLINE HYDROCHLORIDE
Strength
EQ 25MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 018013
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.
- —AVENTYL HYDROCHLORIDEBrand (NDA)
NDA 014684 · LILLY
- —AVENTYLBrand (NDA)
NDA 014685 · RANBAXY
- —PAMELORBrand (NDA)
NDA 018012 · SPECGX LLC
- 2023NORTRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217731 · RUBICON RESEARCH
- 2021NORTRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 213441 · ZYDUS LIFESCIENCES
- 2006NORTRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 077965 · TARO
- 2000NORTRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 075606 · PHARM ASSOC
- 2000NORTRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 075520 · TARO
- 1997NORTRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074835 · AUROBINDO PHARMA LTD
- 1996NORTRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 073667 · TEVA
- 1995NORTRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074132 · TEVA
- 1993NORTRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074234 · RISING
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.
