Last Updated: August 9, 2026

Details for New Drug Application (NDA): 214919

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NDA 214919 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 Pharms Inc, 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, Granules, MSN, Ph Health, Quagen, Sciegen Pharms, Suven Pharms, Appco, Aurobindo Pharma, Hikma Intl Pharms, Lgm Pharma, Natco, Oxford Pharms, Regcon Holdings, Rising, Sun Pharm Inds Ltd, 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 are seventeen drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

Summary for 214919

Tradename:	GLYCOPYRROLATE
Applicant:	Fresenius Kabi Usa
Ingredient:	glycopyrrolate
Patents:	0

Pharmacology for NDA: 214919

Mechanism of Action	Cholinergic Antagonists Cholinergic Muscarinic Antagonists

Medical Subject Heading (MeSH) Categories for 214919

Adjuvants, Anesthesia
Muscarinic Antagonists

Suppliers and Packaging for NDA: 214919

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLYCOPYRROLATE	glycopyrrolate	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	214919	NDA	Fresenius Kabi USA, LLC	76045-023	76045-023-30	10 SYRINGE in 1 CARTON (76045-023-30) / 3 mL in 1 SYRINGE (76045-023-00)
GLYCOPYRROLATE	glycopyrrolate	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	214919	NDA	Fresenius Kabi USA, LLC	76045-223	76045-223-30	10 SYRINGE in 1 CARTON (76045-223-30) / 3 mL in 1 SYRINGE (76045-223-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAMUSCULAR, INTRAVENOUS			Strength	0.6MG/3ML (0.2MG/ML)
Approval Date:	Apr 21, 2022	TE:		RLD:	Yes

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