Last Updated: June 24, 2026

Details for New Drug Application (NDA): 209328

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NDA 209328 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, Sciegen Pharms, 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-nine NDAs. It is available from fifty-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. Sixty-two suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

Summary for 209328

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

Pharmacology for NDA: 209328

Mechanism of Action	Cholinergic Antagonists Cholinergic Muscarinic Antagonists

Medical Subject Heading (MeSH) Categories for 209328

Adjuvants, Anesthesia
Muscarinic Antagonists

Suppliers and Packaging for NDA: 209328

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLYCOPYRROLATE	glycopyrrolate	INJECTABLE;INJECTION	209328	ANDA	Fresenius Kabi USA, LLC	63323-578	63323-578-01	25 VIAL, SINGLE-DOSE in 1 CARTON (63323-578-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-578-03)
GLYCOPYRROLATE	glycopyrrolate	INJECTABLE;INJECTION	209328	ANDA	Fresenius Kabi USA, LLC	63323-578	63323-578-02	25 VIAL, SINGLE-DOSE in 1 CARTON (63323-578-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-578-04)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.2MG/ML
Approval Date:	Oct 27, 2017	TE:	AP	RLD:	No

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