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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 210927

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NDA 210927 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-four 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. Fifty-nine suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

Summary for 210927

Tradename:	GLYCOPYRROLATE
Applicant:	Prinston Inc
Ingredient:	glycopyrrolate
Patents:	0

Pharmacology for NDA: 210927

Mechanism of Action	Cholinergic Antagonists Cholinergic Muscarinic Antagonists

Medical Subject Heading (MeSH) Categories for 210927

Adjuvants, Anesthesia
Muscarinic Antagonists

Suppliers and Packaging for NDA: 210927

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLYCOPYRROLATE	glycopyrrolate	INJECTABLE;INJECTION	210927	ANDA	Solco Healthcare US, LLC	43547-543	43547-543-25	25 VIAL, SINGLE-DOSE in 1 CARTON (43547-543-25) / 1 mL in 1 VIAL, SINGLE-DOSE (43547-543-01)
GLYCOPYRROLATE	glycopyrrolate	INJECTABLE;INJECTION	210927	ANDA	Solco Healthcare US, LLC	43547-544	43547-544-25	25 VIAL, SINGLE-DOSE in 1 CARTON (43547-544-25) / 2 mL in 1 VIAL, SINGLE-DOSE (43547-544-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.2MG/ML
Approval Date:	Oct 31, 2018	TE:	AP	RLD:	No

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