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Generated: August 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040653

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NDA 040653 describes GLYCOPYRROLATE, which is a drug marketed by Watson Labs, Appco Pharma Llc, Natco Pharma Ltd, Vintage Pharms, Rising Pharms Inc, Nexgen Pharma, Luitpold, Hikma Intl Pharms, Somerset Theraps Llc, Sun Pharm Inds Ltd, Dr Reddys Labs Ltd, Par Pharm, Hikma Farmaceutica, Epic Pharma Llc, Teva Parenteral, Amneal Pharms Co, Abraxis Pharm, Aurolife Pharma Llc, Santos Biotech, Hospira, and Leading Pharma Llc, and is included in twenty-six NDAs. It is available from twenty-seven suppliers. Additional details are available on the GLYCOPYRROLATE profile page.

The generic ingredient in GLYCOPYRROLATE is glycopyrrolate. There are fifteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

Summary for NDA: 040653

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 040653

Mechanism of ActionCholinergic Antagonists

Suppliers and Packaging for NDA: 040653

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYCOPYRROLATE
glycopyrrolate
TABLET;ORAL 040653 ANDA Par Formulations Private Limited 43227-065 43227-065-01 100 TABLET in 1 BOTTLE (43227-065-01)
GLYCOPYRROLATE
glycopyrrolate
TABLET;ORAL 040653 ANDA Par Formulations Private Limited 43227-066 43227-066-01 100 TABLET in 1 BOTTLE (43227-066-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Aug 31, 2006TE:AARLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Aug 31, 2006TE:AARLD:No


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Serving 500+ biopharmaceutical companies globally:

McKinsey
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Colorcon

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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