DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 012827
NDA 012827 describes ROBINUL FORTE, which is a drug marketed by Casper Pharma Llc and is included in one NDA. It is available from one supplier. 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. Thirty-eight suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
The generic ingredient in ROBINUL FORTE 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 012827
| Tradename: | ROBINUL FORTE |
| Applicant: | Casper Pharma Llc |
| Ingredient: | glycopyrrolate |
| Patents: | 0 |
| Therapeutic Class: | Gastrointestinal Agents |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 012827
| Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 012827
Suppliers and Packaging for NDA: 012827
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ROBINUL | glycopyrrolate | TABLET;ORAL | 012827 | NDA | Shionogi Inc. | 59630-200 | E | 59630-200-10 |
| ROBINUL FORTE | glycopyrrolate | TABLET;ORAL | 012827 | NDA | Shionogi Inc. | 59630-200 | E | 59630-200-10 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| 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 | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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