Last Updated: May 11, 2026

Details for New Drug Application (NDA): 204438

✉ Email this page to a colleague

« Back to Dashboard

NDA 204438 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 204438

Tradename:	GLYCOPYRROLATE
Applicant:	Ph Health
Ingredient:	glycopyrrolate
Patents:	0

Pharmacology for NDA: 204438

Mechanism of Action	Cholinergic Antagonists Cholinergic Muscarinic Antagonists

Medical Subject Heading (MeSH) Categories for 204438

Adjuvants, Anesthesia
Muscarinic Antagonists

Suppliers and Packaging for NDA: 204438

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLYCOPYRROLATE	glycopyrrolate	SOLUTION;ORAL	204438	ANDA	Endo USA, Inc.	49884-042	49884-042-33	16 mL in 1 BOTTLE (49884-042-33)
GLYCOPYRROLATE	glycopyrrolate	SOLUTION;ORAL	204438	ANDA	Bryant Ranch Prepack	63629-9592	63629-9592-1	473 mL in 1 BOTTLE (63629-9592-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	1MG/5ML
Approval Date:	Aug 9, 2021	TE:	AA	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.