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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Accenture
Federal Trade Commission
Daiichi Sankyo
Mallinckrodt
Harvard Business School
Merck
Farmers Insurance
Teva

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091522

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NDA 091522 describes GLYCOPYRROLATE, which is a drug marketed by Abraxis Pharm, Amneal Pharms Co, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Luitpold, Somerset Theraps Llc, Teva Parenteral, Watson Labs, Appco Pharma Llc, Aurolife Pharma Llc, Dr Reddys Labs Ltd, Epic Pharma Llc, Hikma Intl Pharms, Leading Pharma Llc, Natco Pharma Ltd, Nexgen Pharma, Par Pharm, Rising Pharms Inc, Santos Biotech, Sun Pharm Inds Ltd, and Vintage Pharms, and is included in twenty-seven NDAs. It is available from twenty-six suppliers. Additional details are available on the GLYCOPYRROLATE profile page.

The generic ingredient in GLYCOPYRROLATE is glycopyrrolate. There are seventeen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
Summary for 091522
Tradename:GLYCOPYRROLATE
Applicant:Nexgen Pharma
Ingredient:glycopyrrolate
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091522
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 091522
Suppliers and Packaging for NDA: 091522
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 091522 ANDA Nexgen Pharma, Inc. 0722-7097 N 0722-7097-01
GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 091522 ANDA Nuro Pharma, Inc. 59547-210 N 59547-210-19

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.5MG
Approval Date:Mar 12, 2012TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Johnson and Johnson
Fish and Richardson
Dow
Moodys
Chinese Patent Office
Deloitte
US Department of Justice
Daiichi Sankyo

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