Orange Book product · Brand (NDA)
OPANA
OXYMORPHONE HYDROCHLORIDE
At a glance
Jun 22, 2006
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 22, 2006
20 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
OXYMORPHONE HYDROCHLORIDE
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 021611
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2011OPANA ERBrand (NDA)
NDA 201655 · ENDO PHARMS
- 2006OPANA ERBrand (NDA)
NDA 021610 · ENDO OPERATIONS
- —OPANABrand (NDA)
NDA 011707 · ENDO PHARMS
- —NUMORPHANBrand (NDA)
NDA 011738 · ENDO PHARMS
- 2018OXYMORPHONE HYDROCHLORIDEGeneric (ANDA)
ANDA 210175 · ASCENT PHARMS INC
- 2016OXYMORPHONE HYDROCHLORIDEGeneric (ANDA)
ANDA 204459 · AUROLIFE PHARMA LLC
- 2015OXYMORPHONE HYDROCHLORIDEGeneric (ANDA)
ANDA 203506 · SUN PHARM INDS LTD
- 2014OXYMORPHONE HYDROCHLORIDEGeneric (ANDA)
ANDA 201187 · EPIC PHARMA LLC
- 2014OXYMORPHONE HYDROCHLORIDEGeneric (ANDA)
ANDA 200792 · PAR PHARM
- 2014OXYMORPHONE HYDROCHLORIDEGeneric (ANDA)
ANDA 202946 · SPECGX LLC
- 2013OXYMORPHONE HYDROCHLORIDEGeneric (ANDA)
ANDA 200822 · HIKMA
- 2013OXYMORPHONE HYDROCHLORIDEGeneric (ANDA)
ANDA 079046 · ACTAVIS ELIZABETH
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
