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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 091522

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NDA 091522 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 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-six suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

Summary for 091522

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

Pharmacology for NDA: 091522

Mechanism of Action	Cholinergic Antagonists Cholinergic Muscarinic Antagonists

Medical Subject Heading (MeSH) Categories for 091522

Adjuvants, Anesthesia
Muscarinic Antagonists

Suppliers and Packaging for NDA: 091522

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	091522	ANDA	FH2 Pharma LLC	72887-160	72887-160-03	30 TABLET in 1 BOTTLE (72887-160-03)
GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	091522	ANDA	LGM PHARMA SOLUTIONS, LLC	79739-7097	79739-7097-1	100 TABLET in 1 BOTTLE, PLASTIC (79739-7097-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1.5MG
Approval Date:	Mar 12, 2012	TE:		RLD:	No

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