Last Updated: April 29, 2026

Details for New Drug Application (NDA): 207639

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NDA 207639 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-eight 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-one suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

Summary for 207639

Tradename:	GLYCOPYRROLATE
Applicant:	Somerset Theraps Llc
Ingredient:	glycopyrrolate
Patents:	0

Pharmacology for NDA: 207639

Mechanism of Action	Cholinergic Antagonists Cholinergic Muscarinic Antagonists

Medical Subject Heading (MeSH) Categories for 207639

Adjuvants, Anesthesia
Muscarinic Antagonists

Suppliers and Packaging for NDA: 207639

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLYCOPYRROLATE	glycopyrrolate	INJECTABLE;INJECTION	207639	ANDA	Somerset Therapeutics, LLC	70069-616	70069-616-10	10 VIAL in 1 CARTON (70069-616-10) / 20 mL in 1 VIAL (70069-616-01)
GLYCOPYRROLATE	glycopyrrolate	INJECTABLE;INJECTION	207639	ANDA	Somerset Therapeutics, LLC	70069-617	70069-617-25	25 VIAL in 1 CARTON (70069-617-25) / 1 mL in 1 VIAL (70069-617-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.2MG/ML
Approval Date:	Jun 23, 2017	TE:	AP	RLD:	No

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