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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 Roxane, Epic Pharma Llc, and Sigmapharm Labs Llc, and is included in three NDAs. It is available from four 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. Four suppliers are listed for this compound. Additional details are available on the protriptyline hydrochloride profile page.

Summary for NDA: 202220

Epic Pharma Llc
protriptyline hydrochloride
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for NDA: 202220

Suppliers and Packaging for NDA: 202220

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
TABLET;ORAL 202220 ANDA Epic Pharma, LLC 42806-096 42806-096-10 1000 TABLET, FILM COATED in 1 BOTTLE (42806-096-10)

Summary for product number 001

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

Summary for product number 002

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

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