Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Harvard Business School
UBS
Federal Trade Commission
Johnson and Johnson
US Department of Justice
Colorcon
QuintilesIMS
Dow

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090462

« Back to Dashboard

NDA 090462 describes PROTRIPTYLINE HYDROCHLORIDE, which is a drug marketed by Epic Pharma Llc, Sigmapharm Labs Llc, and West-ward Pharms Int, 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 090462
Tradename:PROTRIPTYLINE HYDROCHLORIDE
Applicant:Sigmapharm Labs Llc
Ingredient:protriptyline hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Pharmacology for NDA: 090462
Medical Subject Heading (MeSH) Categories for 090462
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 Rising Pharmaceuticals, Inc 64980-158 N 64980-158-01
PROTRIPTYLINE HYDROCHLORIDE protriptyline hydrochloride TABLET;ORAL 090462 ANDA Rising Pharmaceuticals, Inc 64980-159 N 64980-159-01

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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Daiichi Sankyo
Farmers Insurance
QuintilesIMS
Accenture
Boehringer Ingelheim
Argus Health
Dow
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.