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OXYMORPHONE

 
 
Content specific to this active ingredient…

Drug Information
Prescribing and patient information from leading authorities

Drug Master Files
Type 2 master files on file at the FDA

Safety Information
For prescription drugs containing this active ingredient

Exclusivity
Patent and market exclusivity data

Federal Register
FR search results for this API

FDA Approved Labelling
Information found in this drug's package inserts

Research Links
Chemical identification and research citations

Title 21 Code of Federal Regulations
FDA regulations for this API

 
 
 
 
 
 
 
 

 


 

FDA Approval Activities for this Drug…

OXYMORPHONE HYDROCHLORIDE Injection 1.5MG/ML NUMORPHAN ENDO 011707 OXYMORPHONE HYDROCHLORIDE Injection 1MG/ML NUMORPHAN ENDO 011738 OXYMORPHONE HYDROCHLORIDE Suppository; Rectal 5MG NUMORPHAN ENDO | Opana (Oxymorphone Hydrochloride) Extended-Release Tablets, Endo Pharma, Approval | Opana (Oxymorphone Hydrochloride) Tablets, Endo Pharma, Approval | Opana ER (Oxymorphone Hydrochloride) Extended-Release Tablets, Endo Pharma, Labeling Revision | Opana (Oxymorphone Hydrochloride) Immediate-Release Tablets, Endo Pharma, Labeling Revision | OPANA (Oxymorphone Hydrochloride) Injection, Endo Pharma, Labeling Revision | Opana ER (Oxymorphone Hydrochloride) Extended-Release Tablets, Endo Pharma, Labeling Revision | OPANA ER (oxymorphone HCl) Extended-Release Tablets, Endo Pharma, Control Supplement | OPANA ER (oxymorphone hydrochloride) Extended-Release Tablets, Endo Pharma, Manufacturing Change or Addition | Oxymorphone Hydrochloride Extended-Release Tablets, Impax Laboratories, Inc., Tentative Approval | Oxymorphone Hydrochloride Extended-Release Tablets, Impax Laboratories, Inc., Approval | Oxymorphone Hydrochloride Tablets, Roxane Laboratories, Inc., Approval | Opana ER (oxymorphone hydrochloride) Tablets, Endo Pharmaceuticals, Inc., Labeling Revision | Oxymorphone Hydrochloride Extended-Release Tablets, Actavis South Atlantic LLC, Approval and Tentative Approval | Oxymorphone Hydrochloride Extended-Release Tablets, Impax Laboratories, Inc., Approval | Opana (oxymorphone hydrochloride) Tablets, Endo Pharmaceuticals, Inc., Labeling Revision | Oxymorphone Hydrochloride Tablets, Teva Pharmaceuticals, Approval | Opana (oxymorphone hydrochloride) Extended-Release Tablets, Endo Pharmaceuticals Inc., Approval

^ FDA's latest approval appears at the bottom of this list. ^

                                                                   

 

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