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Details for New Drug Application (NDA): 071297

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NDA 071297 describes CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE, which is a drug marketed by Watson Labs, Frontida Biopharm, Par Pharm, Usl Pharma, and Mylan Pharms Inc, and is included in nine 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.

Summary for NDA: 071297

Pharmacology for NDA: 071297

Ingredient-typeBenzodiazepines

Suppliers and Packaging for NDA: 071297

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
amitriptyline hydrochloride; chlordiazepoxide
TABLET;ORAL 071297 ANDA Mylan Pharmaceuticals Inc. 0378-0211 0378-0211-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0211-01)
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
amitriptyline hydrochloride; chlordiazepoxide
TABLET;ORAL 071297 ANDA Mylan Pharmaceuticals Inc. 0378-0211 0378-0211-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0211-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE;10MG
Approval Date:Dec 10, 1986TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 12.5MG BASE;5MG
Approval Date:Dec 10, 1986TE:RLD:No


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