Last Updated: November 8, 2026

Details for New Drug Application (NDA): 212227

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NDA 212227 describes GLYCOPYRROLATE, which is a drug marketed by Abraxis Pharm, Accord Hlthcare, Alembic, Am Regent, Amneal, Apotex, Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma Farmaceutica, Hospira, Lupin, Mankind Pharma, Meitheal, Nivagen, Omnivium Pharms, Piramal Critical, Prinston Inc, Sagent, Sandoz, Somerset Theraps Llc, Teva Parenteral, Watson Labs, Xiromed, Zydus Pharms, Ajenat Pharms, Annora Pharma, Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Cohance Lifesciences, Granules, MSN, Ph Health, Quagen, Sciegen Pharms, Appco, Aurobindo Pharma, Hikma, Lgm Pharma, Natco, Regcon Holdings, Rising, Sun Pharm Inds Ltd, Tp Anda Holdings, and Velzen Pharma Pvt, and is included in sixty NDAs. It is available from fifty-eight suppliers. Additional details are available on the GLYCOPYRROLATE profile page.

The generic ingredient in GLYCOPYRROLATE is glycopyrrolate. There is one drug master file entry for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

Summary for 212227

Tradename:	GLYCOPYRROLATE
Applicant:	Xiromed
Ingredient:	glycopyrrolate
Patents:	0

Pharmacology for NDA: 212227

Mechanism of Action	Cholinergic Antagonists

Medical Subject Heading (MeSH) Categories for 212227

Adjuvants, Anesthesia
Muscarinic Antagonists

Suppliers and Packaging for NDA: 212227

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLYCOPYRROLATE	glycopyrrolate	INJECTABLE;INJECTION	212227	ANDA	XIROMED LLC	70700-264	70700-264-22	1 VIAL in 1 CARTON (70700-264-22) / 1 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	0.2MG/ML
Approval Date:	Mar 4, 2021	TE:		RLD:	No

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