Details for New Drug Application (NDA): 206468

NDA 206468 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-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 206468

Tradename:	DICYCLOMINE HYDROCHLORIDE
Applicant:	Nexus
Ingredient:	dicyclomine hydrochloride
Patents:	0

Pharmacology for NDA: 206468

Mechanism of Action

Cholinergic Antagonists

Medical Subject Heading (MeSH) Categories for 206468

Muscarinic Antagonists

Parasympatholytics

Suppliers and Packaging for NDA: 206468

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DICYCLOMINE HYDROCHLORIDE	dicyclomine hydrochloride	INJECTABLE;INJECTION	206468	ANDA	Nexus Pharmaceuticals LLC	14789-010	14789-010-02	5 VIAL, SINGLE-DOSE in 1 CARTON (14789-010-02) / 2 mL in 1 VIAL, SINGLE-DOSE (14789-010-07)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Feb 1, 2019	TE:	AP	RLD:	No

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