BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Drug patents in 130+ countries
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
UBS
Baxter
Accenture
Federal Trade Commission
Express Scripts
Novartis
Dow
Harvard Business School
Colorcon

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017558

« Back to Dashboard

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 five 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-five 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 0641-6033-25 25 VIAL in 1 CARTON (0641-6033-25) > 1 mL in 1 VIAL (0641-6033-01)
ROBINUL glycopyrrolate INJECTABLE;INJECTION 017558 NDA West-ward Pharmaceutical Corp. 0641-6034 0641-6034-25 25 VIAL in 1 CARTON (0641-6034-25) > 2 mL in 1 VIAL (0641-6034-01)

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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Julphar
Boehringer Ingelheim
Cipla
Fish and Richardson
McKinsey
Baxter
Healthtrust
Argus Health
US Department of Justice

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

botpot