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Clinical Use of Anabolics and Hormones
Clinical Use of Anabolics and Hormones
FDA approved, discontinued androgens (FDA orange book)
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<blockquote data-quote="Nelson Vergel" data-source="post: 258912" data-attributes="member: 3"><p>After <strong>FDA notified Gemini that it believes the potential problems associated with the drug are sufficiently serious that the drug should be removed from the market </strong>pursuant to § 314.150(d), Gemini requested in a letter dated December 19, 2022 that FDA withdraw approval of NDA 013718 under § 314.150(d). Gemini waived its opportunity for a hearing. In a letter dated December 23, 2022, Sandoz requested that FDA withdraw approval of ANDA 076897 under § 314.150(d). Sandoz waived its opportunity for a hearing. In a letter dated January 5, 2023, Par requested that FDA withdraw approval of ANDA 077827 under § 314.150(d). Par waived its opportunity for a hearing. In separate letters dated January 6, 2023, Upsher-Smith requested that FDA withdraw approval of ANDAs 078033 and 076761 under § 314.150(d). Upsher-Smith waived its opportunity for a hearing.</p><p></p><p>[URL unfurl="true"]https://www.federalregister.gov/documents/2023/06/28/2023-13733/gemini-laboratories-llc-et-al-withdrawal-of-approval-of-one-new-drug-application-for-oxandrin[/URL]</p></blockquote><p></p>
[QUOTE="Nelson Vergel, post: 258912, member: 3"] After [B]FDA notified Gemini that it believes the potential problems associated with the drug are sufficiently serious that the drug should be removed from the market [/B]pursuant to § 314.150(d), Gemini requested in a letter dated December 19, 2022 that FDA withdraw approval of NDA 013718 under § 314.150(d). Gemini waived its opportunity for a hearing. In a letter dated December 23, 2022, Sandoz requested that FDA withdraw approval of ANDA 076897 under § 314.150(d). Sandoz waived its opportunity for a hearing. In a letter dated January 5, 2023, Par requested that FDA withdraw approval of ANDA 077827 under § 314.150(d). Par waived its opportunity for a hearing. In separate letters dated January 6, 2023, Upsher-Smith requested that FDA withdraw approval of ANDAs 078033 and 076761 under § 314.150(d). Upsher-Smith waived its opportunity for a hearing. [URL unfurl="true"]https://www.federalregister.gov/documents/2023/06/28/2023-13733/gemini-laboratories-llc-et-al-withdrawal-of-approval-of-one-new-drug-application-for-oxandrin[/URL] [/QUOTE]
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Clinical Use of Anabolics and Hormones
Clinical Use of Anabolics and Hormones
FDA approved, discontinued androgens (FDA orange book)
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