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Generated: May 24, 2017

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Details for New Drug Application (NDA): 090462

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NDA 090462 describes PROTRIPTYLINE HYDROCHLORIDE, which is a drug marketed by West-ward Pharms Int, 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: 090462

Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for NDA: 090462

Suppliers and Packaging for NDA: 090462

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
protriptyline hydrochloride
TABLET;ORAL 090462 ANDA Rising Pharmaceuticals, Inc 64980-158 64980-158-01 100 TABLET, FILM COATED in 1 BOTTLE (64980-158-01)
protriptyline hydrochloride
TABLET;ORAL 090462 ANDA Rising Pharmaceuticals, Inc 64980-159 64980-159-01 100 TABLET, FILM COATED in 1 BOTTLE (64980-159-01)

Summary for product number 001

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

Summary for product number 002

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

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