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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 090020

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NDA 090020 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-four 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. Fifty-nine suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

Summary for 090020

Tradename:	GLYCOPYRROLATE
Applicant:	Oxford Pharms
Ingredient:	glycopyrrolate
Patents:	0

Medical Subject Heading (MeSH) Categories for 090020

Adjuvants, Anesthesia
Muscarinic Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Oct 19, 2011	TE:	AA	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Oct 19, 2011	TE:	AA	RLD:	No

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