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Last Updated: March 28, 2024

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. It is available from three suppliers. 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. Fifty-five 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
Pharmacology for NDA: 012827
Mechanism of ActionCholinergic 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 AUTHORIZED GENERIC Rising Pharma Holdings, Inc. 16571-743 16571-743-03 30 TABLET in 1 CONTAINER (16571-743-03)
ROBINUL glycopyrrolate TABLET;ORAL 012827 NDA AUTHORIZED GENERIC Rising Pharma Holdings, Inc. 16571-743 16571-743-09 90 TABLET in 1 CONTAINER (16571-743-09)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:Yes

Expired US Patents for NDA 012827

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Casper Pharma Llc ROBINUL glycopyrrolate TABLET;ORAL 012827-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Casper Pharma Llc ROBINUL FORTE glycopyrrolate TABLET;ORAL 012827-002 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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