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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Citi
Merck
Johnson and Johnson
Boehringer Ingelheim
Cantor Fitzgerald
Federal Trade Commission
Daiichi Sankyo
Covington

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 085223

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NDA 085223 describes DICYCLOMINE HYDROCHLORIDE, which is a drug marketed by Hikma Pharms, Lannett, Mylan, Pioneer Pharms, Sun Pharm Industries, Watson Labs, Luitpold Pharms Inc, Alpharma Us Pharms, Mikart, and West-ward Pharms Int, and is included in nineteen NDAs. It is available from thirty-five suppliers. Additional details are available on the DICYCLOMINE HYDROCHLORIDE profile page.

The generic ingredient in DICYCLOMINE HYDROCHLORIDE is dicyclomine hydrochloride. There are four drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.
Summary for 085223
Tradename:DICYCLOMINE HYDROCHLORIDE
Applicant:Watson Labs
Ingredient:dicyclomine hydrochloride
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 085223
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 085223
Suppliers and Packaging for NDA: 085223
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICYCLOMINE HYDROCHLORIDE dicyclomine hydrochloride TABLET;ORAL 085223 ANDA Actavis Pharma, Inc. 0591-0795 N 0591-0795-01
DICYCLOMINE HYDROCHLORIDE dicyclomine hydrochloride TABLET;ORAL 085223 ANDA Actavis Pharma, Inc. 0591-0795 N 0591-0795-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Jul 30, 1986TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Chubb
Federal Trade Commission
Citi
McKesson
Dow
Argus Health
Johnson and Johnson
US Army

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