Orange Book product · Generic (ANDA)
OXYMORPHONE HYDROCHLORIDE
OXYMORPHONE HYDROCHLORIDE
At a glance
Jul 11, 2013
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 11, 2013
13 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
OXYMORPHONE HYDROCHLORIDE
Strength
5MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
ANDA 079046
Product number
003
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of OXYMORPHONE HYDROCHLORIDE
- 2011OPANA ERBrand (NDA)
NDA 201655 · ENDO PHARMS
- 2006OPANA ERBrand (NDA)
NDA 021610 · ENDO OPERATIONS
- 2006OPANABrand (NDA)
NDA 021611 · ENDO PHARMS
- —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
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.
