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Serving leading biopharmaceutical companies globally:

Teva
Johnson and Johnson
Federal Trade Commission
Mallinckrodt
Cantor Fitzgerald
McKesson
Daiichi Sankyo
QuintilesIMS
Accenture
Covington

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040653

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NDA 040653 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-eight 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-five suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
Summary for 040653
Tradename:GLYCOPYRROLATE
Applicant:Par Pharm
Ingredient:glycopyrrolate
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 040653
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 040653
Suppliers and Packaging for NDA: 040653
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 040653 ANDA Par Formulations Private Limited 43227-065 43227-065-01 100 TABLET in 1 BOTTLE (43227-065-01)
GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 040653 ANDA Par Formulations Private Limited 43227-066 43227-066-01 100 TABLET in 1 BOTTLE (43227-066-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Aug 31, 2006TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Aug 31, 2006TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
Accenture
AstraZeneca
Covington
Chubb
Farmers Insurance
Mallinckrodt
US Department of Justice

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