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Last Updated: December 20, 2024

Details for New Drug Application (NDA): 089393

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NDA 089393 describes GLYCOPYRROLATE, which is a drug marketed by Abraxis Pharm, Accord Hlthcare, Alembic, Am Regent, Amneal, Apotex, Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, 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, Annora Pharma, Chartwell Rx, Endo Operations, Granules, Saptalis Pharms, Suven Pharms, Adaptis, Aurobindo Pharma, Dr Reddys Labs Ltd, Heritage Pharms Inc, Hikma Intl Pharms, Lgm Pharma, Natco, Oxford Pharms, Quagen, Rising, Sun Pharm Inds Ltd, and Velzen Pharma Pvt, and is included in fifty-five NDAs. It is available from fifty-one 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-seven suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

Summary for 089393

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

Medical Subject Heading (MeSH) Categories for 089393

Adjuvants, Anesthesia
Muscarinic Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	0.2MG/ML
Approval Date:	Jun 15, 1988	TE:		RLD:	No

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