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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Covington
Farmers Insurance
Daiichi Sankyo
Cerilliant
Colorcon
Boehringer Ingelheim
McKinsey
Teva

Generated: June 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017558

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NDA 017558 describes ROBINUL, which is a drug marketed by Robins Ah, West-ward Pharms Int, and Casper Pharma Llc, and is included in three NDAs. It is available from four suppliers. Additional details are available on the ROBINUL profile page.

The generic ingredient in ROBINUL 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 017558
Tradename:ROBINUL
Applicant:West-ward Pharms Int
Ingredient:glycopyrrolate
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 017558
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 017558
Suppliers and Packaging for NDA: 017558
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROBINUL glycopyrrolate INJECTABLE;INJECTION 017558 NDA West-ward Pharmaceutical Corp. 0641-6033 N 0641-6033-25
ROBINUL glycopyrrolate INJECTABLE;INJECTION 017558 NDA West-ward Pharmaceutical Corp. 0641-6034 N 0641-6034-25

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Harvard Business School
Accenture
Cipla
Cerilliant
Mallinckrodt
Covington
Citi
Fish and Richardson

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