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Last Updated: October 4, 2024

Test - Generic Drug Details


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Generic filers with tentative approvals for TEST
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up30MG/1.5ML ACTUATIONSOLUTION, METERED;TRANSDERMAL
⤷  Sign Up⤷  Sign Up750MG/3ML (250MG/ML)INJECTABLE;INTRAMUSCULAR

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 test

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb TESLAC testolactone TABLET;ORAL 016118-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Elkins Sinn TESTOSTERONE PROPIONATE testosterone propionate INJECTABLE;INJECTION 080276-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-003 Sep 28, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Marius Pharms Llc KYZATREX testosterone undecanoate CAPSULE;ORAL 213953-001 Jul 27, 2022 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Besins Hlthcare ANDROGEL testosterone GEL;TRANSDERMAL 022309-002 Sep 7, 2012 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-002 Sep 28, 2018 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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