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Last Updated: September 27, 2020

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Details for New Drug Application (NDA): 202220

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NDA 202220 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 six 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. Six suppliers are listed for this compound. Additional details are available on the protriptyline hydrochloride profile page.
Summary for 202220
Tradename:PROTRIPTYLINE HYDROCHLORIDE
Applicant:Epic Pharma Llc
Ingredient:protriptyline hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202220
Medical Subject Heading (MeSH) Categories for 202220
Suppliers and Packaging for NDA: 202220
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROTRIPTYLINE HYDROCHLORIDE protriptyline hydrochloride TABLET;ORAL 202220 ANDA Epic Pharma, LLC 42806-096 42806-096-01 100 TABLET, FILM COATED in 1 BOTTLE (42806-096-01)
PROTRIPTYLINE HYDROCHLORIDE protriptyline hydrochloride TABLET;ORAL 202220 ANDA Epic Pharma, LLC 42806-096 42806-096-10 1000 TABLET, FILM COATED in 1 BOTTLE (42806-096-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Nov 19, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Nov 19, 2012TE:ABRLD:No

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