Details for New Drug Application (NDA): 210979

NDA 210979 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 210979

Tradename:	DICYCLOMINE HYDROCHLORIDE
Applicant:	Fosun Pharma
Ingredient:	dicyclomine hydrochloride
Patents:	0

Pharmacology for NDA: 210979

Mechanism of Action

Cholinergic Antagonists

Medical Subject Heading (MeSH) Categories for 210979

Muscarinic Antagonists

Parasympatholytics

Suppliers and Packaging for NDA: 210979

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DICYCLOMINE HYDROCHLORIDE	dicyclomine hydrochloride	INJECTABLE;INJECTION	210979	ANDA	Fosun Pharma USA Inc.	72266-127	72266-127-05	5 VIAL, SINGLE-DOSE in 1 CARTON (72266-127-05) / 2 mL in 1 VIAL, SINGLE-DOSE (72266-127-01)

Profile for product number 001

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

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