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Last Updated: November 24, 2024

5-alpha Reductase Inhibitor Drug Class List


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Drugs in Drug Class: 5-alpha Reductase Inhibitor

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Waylis Therap AVODART dutasteride CAPSULE;ORAL 021319-001 Nov 20, 2001 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ascent Pharms Inc DUTASTERIDE dutasteride CAPSULE;ORAL 206574-001 Oct 21, 2016 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma Ltd DUTASTERIDE dutasteride CAPSULE;ORAL 202660-001 Nov 20, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Humanwell Puracap DUTASTERIDE dutasteride CAPSULE;ORAL 209909-001 Nov 21, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Lifesciences DUTASTERIDE dutasteride CAPSULE;ORAL 204373-001 Oct 4, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Strides Pharma DUTASTERIDE dutasteride CAPSULE;ORAL 204262-001 Nov 20, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal Pharms DUTASTERIDE dutasteride CAPSULE;ORAL 203118-001 Nov 20, 2015 AB RX 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

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