Unlock regulatory insights with Watson. Learn More

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

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
VIEW ALL (1)Primary Documents