BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Harvard Business School
Fish and Richardson
Daiichi Sankyo
Boehringer Ingelheim
Queensland Health

Generated: November 21, 2017

DrugPatentWatch Database Preview

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. Thirteen suppliers are listed for this compound. Additional details are available on the pilocarpine hydrochloride profile page.

Summary for 020237

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
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)
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)

Summary for product number 001

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

Summary for product number 002

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

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Serving leading biopharmaceutical companies globally:

Argus Health
Queensland Health
Express Scripts
Fish and Richardson

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