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Details for New Drug Application (NDA): 012827
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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
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: | DISCN | Dosage: | TABLET;ORAL | Strength | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes |
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