Details for New Drug Application (NDA): 207076

NDA 207076 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 207076

Tradename:	DICYCLOMINE HYDROCHLORIDE
Applicant:	Slate Run Pharma
Ingredient:	dicyclomine hydrochloride
Patents:	0

Pharmacology for NDA: 207076

Mechanism of Action

Cholinergic Antagonists

Medical Subject Heading (MeSH) Categories for 207076

Muscarinic Antagonists

Parasympatholytics

Suppliers and Packaging for NDA: 207076

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DICYCLOMINE HYDROCHLORIDE	dicyclomine hydrochloride	INJECTABLE;INJECTION	207076	ANDA	Slate Run Pharmaceuticals, LLC	70436-147	70436-147-81	5 VIAL, SINGLE-DOSE in 1 BOX (70436-147-81) / 2 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Nov 2, 2018	TE:	AP	RLD:	No

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