Aventyl Hydrochloride
Nortriptyline Hydrochloride
Sourced from the FDA Orange Book
Key dates
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Pharmaceutical detail
Active ingredient
NORTRIPTYLINE HYDROCHLORIDE
Strength
EQ 25MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 014684
Product number
002
Marketing status
Discontinued
Reference listed drug (RLD)
No
Reference standard (RS)
No
Other strengths in NDA 014684
Active-ingredient family
This is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- —PamelorBrand (NDA)
NDA 018013 · Specgx LLC
- —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
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.
Aventyl Hydrochloride — frequently asked questions
Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.
Built directly from the FDA Orange Book data file. This product page links back to the Nortriptyline Hydrochloride active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.

