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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 090963

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NDA 090963 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 090963

Tradename:	GLYCOPYRROLATE
Applicant:	Hikma Farmaceutica
Ingredient:	glycopyrrolate
Patents:	0

Pharmacology for NDA: 090963

Mechanism of Action	Cholinergic Antagonists Cholinergic Muscarinic Antagonists

Medical Subject Heading (MeSH) Categories for 090963

Adjuvants, Anesthesia
Muscarinic Antagonists

Suppliers and Packaging for NDA: 090963

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLYCOPYRROLATE	glycopyrrolate	INJECTABLE;INJECTION	090963	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9584	0143-9584-10	10 VIAL, MULTI-DOSE in 1 CARTON (0143-9584-10) / 20 mL in 1 VIAL, MULTI-DOSE (0143-9584-01)
GLYCOPYRROLATE	glycopyrrolate	INJECTABLE;INJECTION	090963	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9585	0143-9585-25	25 VIAL, MULTI-DOSE in 1 CARTON (0143-9585-25) / 5 mL in 1 VIAL, MULTI-DOSE (0143-9585-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.2MG/ML
Approval Date:	Sep 21, 2011	TE:	AP	RLD:	No

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