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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 218310

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NDA 218310 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 218310

Tradename:	DICYCLOMINE HYDROCHLORIDE
Applicant:	Prinston Inc
Ingredient:	dicyclomine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 218310

Muscarinic Antagonists
Parasympatholytics

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Jun 6, 2025	TE:	AB	RLD:	No

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