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Last Updated: December 28, 2025

Details for New Drug Application (NDA): 212591

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NDA 212591 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 Ltd, Mankind Pharma, Meitheal, Omnivium Pharms, Piramal Critical, Prinston Inc, Sagent, Sandoz, Somerset Theraps Llc, Teva Parenteral, Umedica, Watson Labs, Xiromed, Zydus Pharms, Ajenat Pharms, Annora Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Granules, MSN, Ph Health, Sciegen Pharms Inc, Suven Pharms, Appco, Aurobindo Pharma, Hikma Intl Pharms, Lgm Pharma, Natco, Oxford Pharms, Quagen, Regcon Holdings, Rising, Sun Pharm Inds Ltd, and Velzen Pharma Pvt, and is included in fifty-eight NDAs. It is available from fifty-six 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. Sixty suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

Summary for 212591

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

Pharmacology for NDA: 212591

Mechanism of Action	Cholinergic Antagonists

Medical Subject Heading (MeSH) Categories for 212591

Adjuvants, Anesthesia
Muscarinic Antagonists

Suppliers and Packaging for NDA: 212591

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLYCOPYRROLATE	glycopyrrolate	INJECTABLE;INJECTION	212591	ANDA	Nivagen Pharmaceuticals, Inc.	75834-193	75834-193-25	25 VIAL, SINGLE-DOSE in 1 CARTON (75834-193-25) / 1 mL in 1 VIAL, SINGLE-DOSE
GLYCOPYRROLATE	glycopyrrolate	INJECTABLE;INJECTION	212591	ANDA	Nivagen Pharmaceuticals, Inc.	75834-194	75834-194-25	25 VIAL, SINGLE-DOSE in 1 CARTON (75834-194-25) / 2 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.2MG/ML
Approval Date:	Oct 13, 2021	TE:	AP	RLD:	No

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