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Last Updated: March 28, 2024

Dyclonine hydrochloride - Generic Drug Details


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What are the generic sources for dyclonine hydrochloride and what is the scope of freedom to operate?

Dyclonine hydrochloride is the generic ingredient in two branded drugs marketed by Astrazeneca and Septodont, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for dyclonine hydrochloride. One supplier is listed for this compound.

Summary for dyclonine hydrochloride
Recent Clinical Trials for dyclonine hydrochloride

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

SponsorPhase
Changhai HospitalPhase 4
Aaron Cumpston, PharmD, BCOPPhase 2
Aaron Cumpston, PharmDPhase 2

See all dyclonine hydrochloride clinical trials

US Patents and Regulatory Information for dyclonine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Septodont DYCLOPRO dyclonine hydrochloride SOLUTION;TOPICAL 200480-001 Nov 20, 2018 RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca DYCLONE dyclonine hydrochloride SOLUTION;TOPICAL 009925-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Septodont DYCLOPRO dyclonine hydrochloride SOLUTION;TOPICAL 200480-002 Nov 20, 2018 RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca DYCLONE dyclonine hydrochloride SOLUTION;TOPICAL 009925-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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