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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 211925


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NDA 211925 describes CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE, which is a drug marketed by Anda Repository, Chartwell Rx, Heritage Pharma, Micro Labs, Mylan Pharms Inc, and Usl Pharma, and is included in ten NDAs. It is available from two suppliers. Additional details are available on the CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE profile page.

The generic ingredient in CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE is amitriptyline hydrochloride; chlordiazepoxide. There are thirteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride; chlordiazepoxide profile page.
Pharmacology for NDA: 211925
Suppliers and Packaging for NDA: 211925
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride; chlordiazepoxide TABLET;ORAL 211925 ANDA Micro Labs Limited 42571-302 42571-302-01 100 TABLET in 1 BOTTLE (42571-302-01)
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride; chlordiazepoxide TABLET;ORAL 211925 ANDA Micro Labs Limited 42571-302 42571-302-05 500 TABLET in 1 BOTTLE (42571-302-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 12.5MG BASE;5MG
Approval Date:Feb 2, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE;10MG
Approval Date:Feb 2, 2022TE:ABRLD:No

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