Last Updated: May 3, 2026

Details for New Drug Application (NDA): 088475

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NDA 088475 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-seven 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 088475

Tradename:	GLYCOPYRROLATE
Applicant:	Abraxis Pharm
Ingredient:	glycopyrrolate
Patents:	0

Medical Subject Heading (MeSH) Categories for 088475

Adjuvants, Anesthesia
Muscarinic Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	0.2MG/ML
Approval Date:	Jun 12, 1984	TE:		RLD:	No

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