Orange Book product · Brand (NDA)
ROXYBOND
OXYCODONE HYDROCHLORIDE
At a glance
Apr 20, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 20, 2017
9 yr 4 mo ago
Today
Patent 10314788 expires
Listed drug product patent expiration.
Aug 12, 2028
in 2 yr 2 mo
Patent 7955619 expires
Listed drug product patent expiration.
Aug 12, 2028
in 2 yr 2 mo
Pharmaceutical detail
Active ingredient
OXYCODONE HYDROCHLORIDE
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 209777
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2013OXYCODONE HYDROCHLORIDEBrand (NDA)
NDA 200535 · GENUS LIFESCIENCES
- 2012OXYCODONE HYDROCHLORIDEBrand (NDA)
NDA 201194 · VISTAPHARM LLC
- 2011OXAYDOBrand (NDA)
NDA 202080 · ZYLA
- 2010OXYCODONE HYDROCHLORIDEBrand (NDA)
NDA 200534 · GENUS LIFESCIENCES
- 2010OXYCONTINBrand (NDA)
NDA 022272 · KNOA PHARMA
- 1998ROXICODONEBrand (NDA)
NDA 020932 · ROXANE
- 2025OXYCODONE HYDROCHLORIDEGeneric (ANDA)
ANDA 207418 · ASCENT PHARMS INC
- 2021OXYCODONE HYDROCHLORIDEGeneric (ANDA)
ANDA 213761 · QUAGEN
- 2020OXYCODONE HYDROCHLORIDEGeneric (ANDA)
ANDA 205853 · RHODES PHARMS
- 2020OXYCODONE HYDROCHLORIDEGeneric (ANDA)
ANDA 212429 · AUROLIFE PHARMA LLC
- 2019OXYCODONE HYDROCHLORIDEGeneric (ANDA)
ANDA 211748 · ALKEM LABS LTD
- 2019OXYCODONE HYDROCHLORIDEGeneric (ANDA)
ANDA 211749 · ALKEM LABS LTD
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10314788 | Aug 12, 2028 | in 2 yr 2 mo | Product |
| 7955619 | Aug 12, 2028 | in 2 yr 2 mo | Product |

