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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 040169

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NDA 040169 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 forty-six 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. Forty-six suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.

Summary for 040169

Tradename:	DICYCLOMINE HYDROCHLORIDE
Applicant:	Ph Health
Ingredient:	dicyclomine hydrochloride
Patents:	0

Pharmacology for NDA: 040169

Mechanism of Action	Cholinergic Antagonists

Medical Subject Heading (MeSH) Categories for 040169

Muscarinic Antagonists
Parasympatholytics

Suppliers and Packaging for NDA: 040169

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DICYCLOMINE HYDROCHLORIDE	dicyclomine hydrochloride	SYRUP;ORAL	040169	ANDA	Endo USA, Inc.	0603-1161	0603-1161-58	473 mL in 1 BOTTLE, PLASTIC (0603-1161-58)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SYRUP;ORAL			Strength	10MG/5ML
Approval Date:	Mar 24, 2005	TE:	AA	RLD:	No

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