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Last Updated: December 12, 2024

Amantadine - Generic Drug Details


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Generic filers with tentative approvals for AMANTADINE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign UpEQ 68.5MG BASECAPSULE, EXTENDED RELEASE;ORAL
⤷  Sign Up⤷  Sign Up137MGCAPSULE, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for amantadine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Supernus Pharms GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-001 Aug 24, 2017 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Supernus Pharms OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-002 Feb 16, 2018 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rising AMANTADINE HYDROCHLORIDE amantadine hydrochloride CAPSULE;ORAL 210129-001 Mar 2, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Supernus Pharms OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-002 Feb 16, 2018 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Supernus Pharms OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-003 Feb 16, 2018 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Endo Operations AMANTADINE HYDROCHLORIDE amantadine hydrochloride SYRUP;ORAL 077992-001 Dec 12, 2006 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Supernus Pharms GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-002 Aug 24, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.