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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 083179

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NDA 083179 describes DICYCLOMINE HYDROCHLORIDE, which is a drug marketed by Annora Pharma, Aurobindo Pharma Usa, Corepharma, Lannett, Pioneer Pharms, Prinston Inc, 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, Alpharma Us Pharms, Endo Operations, Novitium Pharma, Bionpharma, Hikma Pharms, and Rubicon, and is included in thirty-seven NDAs. It is available from fifty-three 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-four suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.

Summary for 083179

Tradename:	DICYCLOMINE HYDROCHLORIDE
Applicant:	Watson Labs
Ingredient:	dicyclomine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 083179

Muscarinic Antagonists
Parasympatholytics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Feb 12, 1986	TE:		RLD:	No

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