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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Cerilliant
Baxter
AstraZeneca
UBS
Citi
Teva
Medtronic
Johnson and Johnson

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040836

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NDA 040836 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-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. Thirty-seven suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
Summary for 040836
Tradename:GLYCOPYRROLATE
Applicant:Hikma Intl Pharms
Ingredient:glycopyrrolate
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 040836
Suppliers and Packaging for NDA: 040836
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 040836 ANDA West-ward Pharmaceutical Corp 0143-1250 N 0143-1250-01
GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 040836 ANDA West-ward Pharmaceutical Corp 0143-1251 N 0143-1251-01

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1MG
Approval Date:Mar 5, 2009TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength2MG
Approval Date:Mar 5, 2009TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Healthtrust
Chubb
AstraZeneca
Fish and Richardson
Colorcon
Federal Trade Commission
Harvard Business School
Fuji

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