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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Citi
Daiichi Sankyo
Argus Health
Cantor Fitzgerald
Healthtrust
Cerilliant
Baxter
Julphar
US Department of Justice

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 089335

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NDA 089335 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 089335
Tradename:GLYCOPYRROLATE
Applicant:Luitpold
Ingredient:glycopyrrolate
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 089335
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 089335
Suppliers and Packaging for NDA: 089335
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYCOPYRROLATE glycopyrrolate INJECTABLE;INJECTION 089335 ANDA American Regent, Inc. 0517-4601 0517-4601-25 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-4601-25) > 1 mL in 1 VIAL, SINGLE-DOSE
GLYCOPYRROLATE glycopyrrolate INJECTABLE;INJECTION 089335 ANDA American Regent, Inc. 0517-4602 0517-4602-25 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-4602-25) > 2 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.2MG/ML
Approval Date:Jul 23, 1986TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Deloitte
UBS
AstraZeneca
Teva
Covington
Chinese Patent Office
Colorcon
Cerilliant
Merck

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