Details for New Drug Application (NDA): 216419

NDA 216419 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 216419

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

Pharmacology for NDA: 216419

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

Suppliers and Packaging for NDA: 216419

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	216419	ANDA	Aurobindo Pharma Limited	59651-524	59651-524-01	100 CAPSULE in 1 BOTTLE (59651-524-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	5MG;2.5MG
Approval Date:	Sep 14, 2023	TE:	AB	RLD:	No

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