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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 090462


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NDA 090462 describes PROTRIPTYLINE HYDROCHLORIDE, which is a drug marketed by Epic Pharma Llc, Hikma, and Sigmapharm Labs Llc, and is included in three NDAs. It is available from two suppliers. Additional details are available on the PROTRIPTYLINE HYDROCHLORIDE profile page.

The generic ingredient in PROTRIPTYLINE HYDROCHLORIDE is protriptyline hydrochloride. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the protriptyline hydrochloride profile page.
Summary for 090462
Tradename:PROTRIPTYLINE HYDROCHLORIDE
Applicant:Sigmapharm Labs Llc
Ingredient:protriptyline hydrochloride
Patents:0
Pharmacology for NDA: 090462
Medical Subject Heading (MeSH) Categories for 090462
Adrenergic Uptake Inhibitors
Antidepressive Agents, Tricyclic
Suppliers and Packaging for NDA: 090462
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROTRIPTYLINE HYDROCHLORIDE protriptyline hydrochloride TABLET;ORAL 090462 ANDA Sigmapharm Laboratories, LLC 42794-004 42794-004-02 100 TABLET, FILM COATED in 1 BOTTLE (42794-004-02)
PROTRIPTYLINE HYDROCHLORIDE protriptyline hydrochloride TABLET;ORAL 090462 ANDA Sigmapharm Laboratories, LLC 42794-007 42794-007-02 100 TABLET, FILM COATED in 1 BOTTLE (42794-007-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:May 3, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 3, 2010TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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