Last Updated: November 13, 2026

Details for New Drug Application (NDA): 084479

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NDA 084479 describes DICYCLOMINE HYDROCHLORIDE, which is a drug marketed by Annora Pharma, Aurobindo Pharma Usa, Hikma, Lannett, Pioneer Pharms, Prinston Inc, Rising, Rubicon Research, Solgen, Sun Pharm Industries, Twi Pharms, Watson Labs, Am Regent, Dr Reddys, Fosun Pharma, Fresenius Kabi Usa, Nexus, Quagen, Renew Pharms, Slate Run Pharma, Somerset Theraps Llc, Alpharma Us Pharms, Novitium Pharma, Ph Health, and Bionpharma, and is included in forty-three NDAs. It is available from forty-three suppliers. Additional details are available on the DICYCLOMINE HYDROCHLORIDE profile page.

The generic ingredient in DICYCLOMINE HYDROCHLORIDE is dicyclomine hydrochloride. There is one drug master file entry for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.

Summary for 084479

Tradename:	DICYCLOMINE HYDROCHLORIDE
Applicant:	Alpharma Us Pharms
Ingredient:	dicyclomine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 084479

Muscarinic Antagonists
Parasympatholytics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SYRUP;ORAL			Strength	10MG/5ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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