You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 22, 2024

Details for New Drug Application (NDA): 217354

✉ Email this page to a colleague

« Back to Dashboard

NDA 217354 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 217354

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

Pharmacology for NDA: 217354

Mechanism of Action	Cholinergic Antagonists

Medical Subject Heading (MeSH) Categories for 217354

Adjuvants, Anesthesia
Muscarinic Antagonists

Suppliers and Packaging for NDA: 217354

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLYCOPYRROLATE	glycopyrrolate	INJECTABLE;INJECTION	217354	ANDA	Lifestar Pharma LLC	70756-631	70756-631-25	25 VIAL in 1 CARTON (70756-631-25) / 1 mL in 1 VIAL (70756-631-82)
GLYCOPYRROLATE	glycopyrrolate	INJECTABLE;INJECTION	217354	ANDA	Lifestar Pharma LLC	70756-632	70756-632-25	25 VIAL in 1 CARTON (70756-632-25) / 2 mL in 1 VIAL (70756-632-82)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	0.2MG/ML
Approval Date:	Feb 27, 2023	TE:		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. 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.