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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 204438

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NDA 204438 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 204438

Tradename:	GLYCOPYRROLATE
Applicant:	Ph Health
Ingredient:	glycopyrrolate
Patents:	0

Pharmacology for NDA: 204438

Mechanism of Action	Cholinergic Antagonists Cholinergic Muscarinic Antagonists

Medical Subject Heading (MeSH) Categories for 204438

Adjuvants, Anesthesia
Muscarinic Antagonists

Suppliers and Packaging for NDA: 204438

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLYCOPYRROLATE	glycopyrrolate	SOLUTION;ORAL	204438	ANDA	Endo USA, Inc.	49884-042	49884-042-33	16 mL in 1 BOTTLE (49884-042-33)
GLYCOPYRROLATE	glycopyrrolate	SOLUTION;ORAL	204438	ANDA	Bryant Ranch Prepack	63629-9592	63629-9592-1	473 mL in 1 BOTTLE (63629-9592-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	1MG/5ML
Approval Date:	Aug 9, 2021	TE:	AA	RLD:	No

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