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Generated: November 21, 2018

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Details for New Drug Application (NDA): 020237

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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. Twelve suppliers are listed for this compound. Additional details are available on the pilocarpine hydrochloride profile page.
Summary for 020237
Tradename:SALAGEN
Applicant:Eisai Inc
Ingredient:pilocarpine hydrochloride
Patents:0
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 0228-2801-11 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0228-2801-11)
SALAGEN pilocarpine hydrochloride TABLET;ORAL 020237 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 0228-2837 0228-2837-11 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (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

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