Details for New Drug Application (NDA): 215555

NDA 215555 describes CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE, which is a drug marketed by Alembic, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Chartwell Rx, Corepharma, Dr Reddys, Micro Labs, Misemer, Nuvo Pharms Inc, Teva Pharms Usa, Torrent, and Winder Labs Llc, and is included in thirteen NDAs. It is available from fourteen suppliers. Additional details are available on the CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE profile page.

The generic ingredient in CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE is chlordiazepoxide hydrochloride; clidinium bromide. There are nine drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the chlordiazepoxide hydrochloride; clidinium bromide profile page.

Summary for 215555

Tradename:	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
Applicant:	Amneal
Ingredient:	chlordiazepoxide hydrochloride; clidinium bromide
Patents:	0

Pharmacology for NDA: 215555

Mechanism of Action	Cholinergic Antagonists
Physiological Effect	Decreased Parasympathetic Acetylcholine Activity Digestive/GI System Activity Alteration GI Motility Alteration

Suppliers and Packaging for NDA: 215555

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	chlordiazepoxide hydrochloride; clidinium bromide	CAPSULE;ORAL	215555	ANDA	Amneal Pharmaceuticals NY LLC	60219-1677	60219-1677-1	100 CAPSULE in 1 BOTTLE, PLASTIC (60219-1677-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	5MG;2.5MG
Approval Date:	Oct 25, 2021	TE:	AB	RLD:	No

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