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

Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Daiichi Sankyo
Cantor Fitzgerald
Harvard Business School
US Department of Justice

Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020237

« Back to Dashboard

NDA 020237 describes SALAGEN, which is a drug marketed by Eisai Inc and is included in one NDA. It is available from four suppliers. Additional details are available on the SALAGEN profile page.

The generic ingredient in SALAGEN is pilocarpine hydrochloride. There are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the pilocarpine hydrochloride profile page.
Summary for 020237
Applicant:Eisai Inc
Ingredient:pilocarpine hydrochloride
Therapeutic Class:Dental and Oral Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 020237
Suppliers and Packaging for NDA: 020237
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SALAGEN pilocarpine hydrochloride TABLET;ORAL 020237 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 0228-2801 N 0228-2801-11
SALAGEN pilocarpine hydrochloride TABLET;ORAL 020237 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 0228-2837 N 0228-2837-11

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Mar 22, 1994TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG
Approval Date:Apr 18, 2003TE:ABRLD:Yes

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Fish and Richardson
Cantor Fitzgerald
US Department of Justice

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.