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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 213530


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NDA 213530 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, and Torrent, and is included in twelve 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.
Suppliers and Packaging for NDA: 213530
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 213530 ANDA Chartwell RX, LLC 62135-696 62135-696-12 120 CAPSULE in 1 BOTTLE (62135-696-12)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG;2.5MG
Approval Date:Oct 20, 2020TE:ABRLD:No

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