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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 202675

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NDA 202675 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, 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-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 202675

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

Pharmacology for NDA: 202675

Mechanism of Action	Cholinergic Antagonists Cholinergic Muscarinic Antagonists

Medical Subject Heading (MeSH) Categories for 202675

Adjuvants, Anesthesia
Muscarinic Antagonists

Suppliers and Packaging for NDA: 202675

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	202675	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8617	0615-8617-39	30 TABLET in 1 BLISTER PACK (0615-8617-39)
GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	202675	ANDA	Aurolife Pharma LLC	13107-014	13107-014-01	100 TABLET in 1 BOTTLE (13107-014-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Apr 15, 2013	TE:	AA	RLD:	No

Profile for product number 002

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

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