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Serving leading biopharmaceutical companies globally:

Fuji
Cipla
Citi
Harvard Business School
Chinese Patent Office
Colorcon
Argus Health
QuintilesIMS
US Department of Justice
Daiichi Sankyo

Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090963

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NDA 090963 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-six suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
Summary for 090963
Tradename:GLYCOPYRROLATE
Applicant:Hikma Farmaceutica
Ingredient:glycopyrrolate
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090963
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 090963
Suppliers and Packaging for NDA: 090963
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYCOPYRROLATE glycopyrrolate INJECTABLE;INJECTION 090963 ANDA West-Ward Pharmaceutical Corp 0143-9584 N 0143-9584-10
GLYCOPYRROLATE glycopyrrolate INJECTABLE;INJECTION 090963 ANDA West-Ward Pharmaceutical Corp 0143-9585 N 0143-9585-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.2MG/ML
Approval Date:Sep 21, 2011TE:APRLD:No

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Argus Health
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Cantor Fitzgerald
Queensland Health
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Mallinckrodt
Merck
UBS
Deloitte

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