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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 210579


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NDA 210579 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 thirteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the chlordiazepoxide hydrochloride; clidinium bromide profile page.
Summary for 210579
Tradename:CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
Applicant:Misemer
Ingredient:chlordiazepoxide hydrochloride; clidinium bromide
Patents:0
Pharmacology for NDA: 210579
Mechanism of ActionCholinergic Antagonists
Physiological EffectDecreased Parasympathetic Acetylcholine Activity
Digestive/GI System Activity Alteration
GI Motility Alteration
Suppliers and Packaging for NDA: 210579
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 210579 ANDA Misemer Pharmaceuticals, Inc 0276-0500 0276-0500-10 100 CAPSULE in 1 BOTTLE (0276-0500-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG;2.5MG
Approval Date:Jul 29, 2020TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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