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Last Updated: November 21, 2024

AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE - Generic Drug Details


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What are the generic sources for amitriptyline hydrochloride; chlordiazepoxide and what is the scope of patent protection?

Amitriptyline hydrochloride; chlordiazepoxide is the generic ingredient in three branded drugs marketed by Anda Repository, Chartwell Rx, Heritage Pharma, Micro Labs, Mylan Pharms Inc, and Usl Pharma, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
Recent Clinical Trials for AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
Federal University of São PauloPhase 4

See all AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE clinical trials

Pharmacology for AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE

US Patents and Regulatory Information for AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms Inc CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride; chlordiazepoxide TABLET;ORAL 071297-001 Dec 10, 1986 AB RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Pharms Inc CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride; chlordiazepoxide TABLET;ORAL 071297-002 Dec 10, 1986 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Heritage Pharma CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride; chlordiazepoxide TABLET;ORAL 072053-001 Dec 16, 1988 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Chartwell Rx LIMBITROL amitriptyline hydrochloride; chlordiazepoxide TABLET;ORAL 016949-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Chartwell Rx LIMBITROL DS amitriptyline hydrochloride; chlordiazepoxide TABLET;ORAL 016949-002 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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