Oxymorphone Injectable Solution

Brand(s)
Opana
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Endo Pharmaceuticals Inc. (2013-02-14)
Oldest Current Product
1959-06-01
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\OXYMORPHONE
FDAOB
INJECTION\INJECTION\OXYMORPHONE HYDROCHLORIDE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION\OXYMORPHONE HYDROCHLORIDE
SPL Moiety
INTRAMUSCULAR\INJECTION\OXYMORPHONE

product(s) by strength(s)

oxymorphone hydrochloride 1 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1634810624OpanaNDAEndo Pharmaceuticals Inc.1959-06-01OXYMORPHONE HYDROCHLORIDEINTRAMUSCULARINJECTIONNDA01170755639e61-8757-11de-8a39-0800200c9a66

application(s)

#idtitleapplicantapproved drug
1NDA011707OPANAENDO PHARMACEUTICALS INCNDA011707_001, NDA011707_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapplication
1NDA011707_001discontinuedOXYMORPHONE HYDROCHLORIDE (1.5MG/ML)INJECTIONFalseOPANA
2NDA011707_002RXOXYMORPHONE HYDROCHLORIDE (1MG/ML)INJECTIONTrueOPANA

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
155639e61-8757-11de-8a39-0800200c9a66 (view SPL)ENDOPHARMACEUTICALS 011403 / February 2013 OPANA (Oxymorphone Hydrochloride) INJECTION1mg/mL CII OpioidAnalgesic Rx onlyprescriptionHuman PrescriptionEndo Pharmaceuticals Inc.MANUFACTURE2013-02-142634810624

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII