Orange Book product · Generic (ANDA)
OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE
At a glance
Jun 02, 2021
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 02, 2021
5 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
OXYCODONE HYDROCHLORIDE
Strength
5MG/5ML
Dosage form
SOLUTION
Route
ORAL
TE code
AA
Application
ANDA 213761
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of OXYCODONE HYDROCHLORIDE
- 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
- 2009ROXICODONEBrand (NDA)
NDA 021011 · SPECGX LLC
- 1998ROXICODONEBrand (NDA)
NDA 020932 · ROXANE
- 2025OXYCODONE HYDROCHLORIDEGeneric (ANDA)
ANDA 207418 · ASCENT PHARMS INC
- 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.
