Upgrade for Complete Access See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson

Last Updated: December 4, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210842

Email this page to a colleague

« Back to Dashboard

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
Applicant:Piramal Critical
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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts

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 verification 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.