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Last Updated: December 4, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210842


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NDA 210842 describes GLYCOPYRROLATE, which is a drug marketed by Abraxis Pharm, Accord Hlthcare, Am Regent, Amneal, Apotex, Athenex Inc, Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Meitheal, Nivagen Pharms Inc, Piramal Critical, Prinston Inc, Sandoz Inc, Somerset Theraps Llc, Teva Parenteral, Watson Labs, Xiromed, Zydus Pharms, Par Pharm Inc, Alembic Labs, Aurolife Pharma Llc, Dr Reddys Labs Ltd, Heritage Pharms Inc, Hikma Intl Pharms, Kenton, Leading Pharma Llc, Lgm Pharma, Natco Pharma Ltd, Oxford Pharms, Par Pharm, Renata, Rising, and Sun Pharm Inds Ltd, and is included in forty-three 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 210842
Tradename:GLYCOPYRROLATE
Applicant:Piramal Critical
Ingredient:glycopyrrolate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 210842
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 210842
Suppliers and Packaging for NDA: 210842
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYCOPYRROLATE glycopyrrolate INJECTABLE;INJECTION 210842 ANDA Piramal Critical Care Inc 66794-202 66794-202-42 25 VIAL, GLASS in 1 CARTON (66794-202-42) > 1 mL in 1 VIAL, GLASS (66794-202-02)
GLYCOPYRROLATE glycopyrrolate INJECTABLE;INJECTION 210842 ANDA Piramal Critical Care Inc 66794-203 66794-203-42 25 VIAL, GLASS in 1 CARTON (66794-203-42) > 2 mL in 1 VIAL, GLASS (66794-203-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.2MG/ML
Approval Date:Oct 25, 2018TE:APRLD:No

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