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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Fuji
Colorcon
Baxter
US Department of Justice
Express Scripts
Moodys
Cipla
US Army
Daiichi Sankyo

Generated: June 23, 2017

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. 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 fifteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

Summary for NDA: 012827

Tradename:
2
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 012827

Mechanism of ActionCholinergic Antagonists

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 59630-200-10 100 TABLET in 1 BOTTLE (59630-200-10)
ROBINUL FORTE
glycopyrrolate
 TABLET;ORAL 012827 NDA Shionogi Inc. 59630-200 59630-200-10 100 TABLET in 1 BOTTLE (59630-200-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:Yes


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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
McKinsey
Argus Health
Novartis
Teva
Farmers Insurance
QuintilesIMS
Healthtrust
US Department of Justice
Mallinckrodt

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.

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