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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 212058

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NDA 212058 describes DICYCLOMINE HYDROCHLORIDE, which is a drug marketed by Annora Pharma, Aurobindo Pharma Usa, Corepharma, Lannett, Pioneer Pharms, Prinston Inc, Rising, Sun Pharm Industries, Twi Pharms, Watson Labs, West Ward, Am Regent, Dr Reddys, Fosun Pharma, Fresenius Kabi Usa, Hikma, Nexus, Praxgen Pharms, Renew Pharms, Slate Run Pharma, Somerset Theraps Llc, Alpharma Us Pharms, Novitium Pharma, Ph Health, Bionpharma, Hikma Pharms, and Rubicon Research, and is included in forty-two NDAs. It is available from fifty suppliers. Additional details are available on the DICYCLOMINE HYDROCHLORIDE profile page.

The generic ingredient in DICYCLOMINE HYDROCHLORIDE is dicyclomine hydrochloride. There are four drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.

Summary for 212058

Tradename:	DICYCLOMINE HYDROCHLORIDE
Applicant:	Praxgen Pharms
Ingredient:	dicyclomine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 212058

Muscarinic Antagonists
Parasympatholytics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Apr 26, 2019	TE:		RLD:	No

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