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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 217354

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NDA 217354 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-five 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 217354

Tradename:	GLYCOPYRROLATE
Applicant:	Mankind Pharma
Ingredient:	glycopyrrolate
Patents:	0

Pharmacology for NDA: 217354

Mechanism of Action	Cholinergic Antagonists

Medical Subject Heading (MeSH) Categories for 217354

Adjuvants, Anesthesia
Muscarinic Antagonists

Suppliers and Packaging for NDA: 217354

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLYCOPYRROLATE	glycopyrrolate	INJECTABLE;INJECTION	217354	ANDA	Lifestar Pharma LLC	70756-631	70756-631-25	25 VIAL in 1 CARTON (70756-631-25) / 1 mL in 1 VIAL (70756-631-82)
GLYCOPYRROLATE	glycopyrrolate	INJECTABLE;INJECTION	217354	ANDA	Lifestar Pharma LLC	70756-632	70756-632-25	25 VIAL in 1 CARTON (70756-632-25) / 2 mL in 1 VIAL (70756-632-82)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	0.2MG/ML
Approval Date:	Feb 27, 2023	TE:		RLD:	No

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