Orange Book product · Brand (NDA)
OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE
At a glance
Jan 12, 2012
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 12, 2012
14 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
OXYCODONE HYDROCHLORIDE
Strength
5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 201194
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.
- 2013OXYCODONE HYDROCHLORIDEBrand (NDA)
NDA 200535 · GENUS LIFESCIENCES
- 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
- 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.
