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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
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Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040844

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NDA 040844 describes GLYCOPYRROLATE, which is a drug marketed by Abraxis Pharm, Amneal Pharms Co, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Luitpold, Somerset Theraps Llc, Teva Parenteral, Watson Labs, Appco Pharma Llc, Aurolife Pharma Llc, Dr Reddys Labs Ltd, Epic Pharma Llc, Hikma Intl Pharms, Leading Pharma Llc, Natco Pharma Ltd, Nexgen Pharma, Par Pharm, Rising Pharms Inc, Santos Biotech, Sun Pharm Inds Ltd, and Vintage Pharms, and is included in twenty-seven NDAs. It is available from twenty-eight suppliers. Additional details are available on the GLYCOPYRROLATE profile page.

The generic ingredient in GLYCOPYRROLATE is glycopyrrolate. There are seventeen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
Summary for 040844
Tradename:GLYCOPYRROLATE
Applicant:Sun Pharm Inds Ltd
Ingredient:glycopyrrolate
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 040844
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 040844
Suppliers and Packaging for NDA: 040844
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 040844 ANDA Ranbaxy Pharmaceuticals Inc. 63304-210 63304-210-69 1 BLISTER PACK in 1 BOX (63304-210-69) > 10 TABLET in 1 BLISTER PACK (63304-210-11)
GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 040844 ANDA Ranbaxy Pharmaceuticals Inc. 63304-210 63304-210-30 30 TABLET in 1 BOTTLE (63304-210-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Aug 18, 2009TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Aug 18, 2009TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Deloitte
Healthtrust
Cerilliant
Federal Trade Commission
Colorcon
Teva
Covington
US Army
QuintilesIMS

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