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Last Updated: May 24, 2024

Mechanism of Action: GABA B Agonists


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Drugs with Mechanism of Action: GABA B Agonists

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Metacel Pharms Llc OZOBAX DS baclofen SOLUTION;ORAL 208193-002 Oct 12, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Metacel Pharms Llc OZOBAX baclofen SOLUTION;ORAL 208193-001 Sep 18, 2019 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal LYVISPAH baclofen GRANULES;ORAL 215422-001 Nov 22, 2021 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Amneal LYVISPAH baclofen GRANULES;ORAL 215422-002 Nov 22, 2021 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Amneal LYVISPAH baclofen GRANULES;ORAL 215422-001 Nov 22, 2021 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Amneal LYVISPAH baclofen GRANULES;ORAL 215422-003 Nov 22, 2021 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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