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Designate Opana® ER (oxymorphone hydrochloride) Extended-release Tablets as a Second RLD for the Purposes of Submitting an ANDA

Type: Non-Rule Making
KeyWord(s) Opana®, Oxymorphone, Hydrochloride, Tablets, NDA 201655, CDER
Short title Designate Opana® ER (oxymorphone hydrochloride) Extended-release Tablets as a Second RLD for the Purposes of Submitting an ANDA
Docket Item Code P
Center CDER

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