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Last Updated: February 28, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 012827


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NDA 012827 describes ROBINUL FORTE, which is a drug marketed by Casper Pharma Llc and is included in one NDA. Additional details are available on the ROBINUL FORTE profile page.

The generic ingredient in ROBINUL FORTE is glycopyrrolate. There are seventeen drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
Summary for 012827
Tradename:ROBINUL FORTE
Applicant:Casper Pharma Llc
Ingredient:glycopyrrolate
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 012827
Adjuvants, Anesthesia
Muscarinic Antagonists
Paragraph IV (Patent) Challenges for 012827
Tradename Dosage Ingredient NDA Submissiondate
ROBINUL FORTE TABLET;ORAL glycopyrrolate 012827 2010-10-12
ROBINUL TABLET;ORAL glycopyrrolate 012827 2010-10-12
ROBINUL TABLET;ORAL glycopyrrolate 012827 2009-08-14
ROBINUL FORTE TABLET;ORAL glycopyrrolate 012827 2009-08-14

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.

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