Orange Book product · Brand (NDA)
ROXICODONE
OXYCODONE HYDROCHLORIDE
At a glance
May 15, 2009
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 15, 2009
17 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
OXYCODONE HYDROCHLORIDE
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 021011
Product number
003
Marketing status
RX
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.
- 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
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.
