Details for New Drug Application (NDA): 216782

NDA 216782 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, Somerset Theraps Llc, Alpharma Us Pharms, Endo Operations, Novitium Pharma, Bionpharma, Hikma Pharms, and Rubicon, and is included in thirty-nine NDAs. It is available from fifty-four 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-five suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.

Summary for 216782

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

Pharmacology for NDA: 216782

Mechanism of Action

Cholinergic Antagonists

Medical Subject Heading (MeSH) Categories for 216782

Muscarinic Antagonists

Parasympatholytics

Suppliers and Packaging for NDA: 216782

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DICYCLOMINE HYDROCHLORIDE	dicyclomine hydrochloride	TABLET;ORAL	216782	ANDA	TWi Pharmaceuticals, Inc.	24979-200	24979-200-01	100 TABLET in 1 BOTTLE, PLASTIC (24979-200-01)
DICYCLOMINE HYDROCHLORIDE	dicyclomine hydrochloride	TABLET;ORAL	216782	ANDA	TWi Pharmaceuticals, Inc.	24979-200	24979-200-02	500 TABLET in 1 BOTTLE, PLASTIC (24979-200-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Jun 1, 2023	TE:	AB	RLD:	No

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