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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
US Department of Justice
Chubb
Express Scripts
Queensland Health
Johnson and Johnson
Mallinckrodt
AstraZeneca
Covington

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 089335

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NDA 089335 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, Hikma Intl Pharms, Leading Pharma Llc, Natco Pharma Ltd, Nexgen Pharma, Par Pharm, Renata, Rising Pharms Inc, Santos Biotech, Sun Pharm Inds Ltd, and Vintage Pharms, and is included in twenty-seven NDAs. It is available from thirty 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-eight suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
Summary for 089335
Tradename:GLYCOPYRROLATE
Applicant:Luitpold
Ingredient:glycopyrrolate
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 089335
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 089335
Suppliers and Packaging for NDA: 089335
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYCOPYRROLATE glycopyrrolate INJECTABLE;INJECTION 089335 ANDA American Regent, Inc. 0517-4601 N 0517-4601-25
GLYCOPYRROLATE glycopyrrolate INJECTABLE;INJECTION 089335 ANDA American Regent, Inc. 0517-4602 N 0517-4602-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.2MG/ML
Approval Date:Jul 23, 1986TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Cantor Fitzgerald
Moodys
Fish and Richardson
Julphar
Chubb
Farmers Insurance
Daiichi Sankyo
US Army

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