Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Generated: September 23, 2019

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, Aurobindo Pharma Ltd, Caplin, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Luitpold, Piramal Critical, Prinston Inc, Sandoz Inc, Somerset Theraps Llc, Teva Parenteral, Watson Labs, Aurolife Pharma Llc, Dr Reddys Labs Ltd, Heritage Pharms Inc, Hikma Intl Pharms, Kenton, Leading Pharma Llc, Natco Pharma Ltd, Nexgen Pharma, Orit Labs Llc, Oxford Pharms, Par Pharm, Renata, Rising, and Sun Pharm Inds Ltd, and is included in thirty-four NDAs. It is available from thirty-nine 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. Forty-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
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 63304-210-01 100 TABLET in 1 BOTTLE (63304-210-01)
GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 040844 ANDA Ranbaxy Pharmaceuticals Inc. 63304-210 63304-210-10 1000 TABLET in 1 BOTTLE (63304-210-10)

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 hundreds of leading biopharmaceutical companies globally:

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Accenture
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Federal Trade Commission

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