Assyro AI

FDA Orange Book · active-ingredient family

Nortriptyline hydrochloride

Nortriptyline hydrochloride is approved as 4 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:PAMELOR · NDA 018013

4

Brand (NDA)

11

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, solution

ProductApplicantApplicationTEApproved
PAMELORRLD×4SPECGX LLCNDA 018013—Approved Prior to Jan 1, 1982
AVENTYLRLDRANBAXYNDA 014685—Approved Prior to Jan 1, 1982
AVENTYL HYDROCHLORIDE×2LILLYNDA 014684—Approved Prior to Jan 1, 1982
PAMELORSPECGX LLCNDA 018012—Approved Prior to Jan 1, 1982

Generic (ANDA) products (11)

ProductApplicantApplicationTEApproved
NORTRIPTYLINE HYDROCHLORIDERUBICON RESEARCHANDA 217731AAAug 15, 2023
NORTRIPTYLINE HYDROCHLORIDE×4ZYDUS LIFESCIENCESANDA 213441—Feb 24, 2021
NORTRIPTYLINE HYDROCHLORIDETAROANDA 077965—Jun 20, 2006
NORTRIPTYLINE HYDROCHLORIDEPHARM ASSOCANDA 075606AAAug 23, 2000
NORTRIPTYLINE HYDROCHLORIDE×4TAROANDA 075520ABMay 08, 2000
NORTRIPTYLINE HYDROCHLORIDE×4AUROBINDO PHARMA LTDANDA 074835—Jun 30, 1997
NORTRIPTYLINE HYDROCHLORIDE×4TEVAANDA 073667—Apr 11, 1996
NORTRIPTYLINE HYDROCHLORIDE×4TEVAANDA 074132ABMar 27, 1995
NORTRIPTYLINE HYDROCHLORIDE×4RISINGANDA 074234—Jul 26, 1993
NORTRIPTYLINE HYDROCHLORIDE×4ANI PHARMSANDA 074054—Dec 31, 1992
NORTRIPTYLINE HYDROCHLORIDE×4DR REDDYS LABS SAANDA 073556ABMar 30, 1992

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.

Nortriptyline hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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