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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Medtronic
US Army
Covington
Cerilliant
McKesson
Deloitte
Healthtrust
Cipla
Mallinckrodt

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207201

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NDA 207201 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 207201
Tradename:GLYCOPYRROLATE
Applicant:Appco Pharma Llc
Ingredient:glycopyrrolate
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 207201
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 207201
Suppliers and Packaging for NDA: 207201
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 207201 ANDA Heritage Pharmaceuticals Inc. 23155-606 23155-606-01 100 TABLET in 1 BOTTLE (23155-606-01)
GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 207201 ANDA Heritage Pharmaceuticals Inc. 23155-607 23155-607-01 100 TABLET in 1 BOTTLE (23155-607-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jan 3, 2017TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Jan 3, 2017TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Merck
Mallinckrodt
Citi
Fuji
QuintilesIMS
Fish and Richardson
Novartis
US Department of Justice

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