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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 203657

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NDA 203657 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 203657

Tradename:	GLYCOPYRROLATE
Applicant:	Alembic
Ingredient:	glycopyrrolate
Patents:	0

Pharmacology for NDA: 203657

Mechanism of Action	Cholinergic Antagonists

Medical Subject Heading (MeSH) Categories for 203657

Adjuvants, Anesthesia
Muscarinic Antagonists

Suppliers and Packaging for NDA: 203657

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	203657	ANDA	Alembic Labs LLC	15955-305	15955-305-01	100 TABLET in 1 BOTTLE, PLASTIC (15955-305-01)
GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	203657	ANDA	Alembic Labs LLC	15955-318	15955-318-01	100 TABLET in 1 BOTTLE, PLASTIC (15955-318-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Nov 30, 2018	TE:	AA	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Nov 30, 2018	TE:	AA	RLD:	No

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