Orange Book product · Brand (NDA)
PERCODAN
ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE
Strength
325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 007337
Product number
006
Marketing status
DISCN
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.
- 1998OXYCODONE AND ASPIRINGeneric (ANDA)
ANDA 040260 · SUN PHARM INDUSTRIES
- 1998OXYCODONE AND ASPIRINGeneric (ANDA)
ANDA 040255 · ANI PHARMS
- 1982CODOXYGeneric (ANDA)
ANDA 087464 · HALSEY
- 1982OXYCODONE AND ASPIRIN (HALF-STRENGTH)Generic (ANDA)
ANDA 087742 · ROXANE
- 1982ROXIPRINGeneric (ANDA)
ANDA 087743 · ROXANE
- 1982OXYCODONE AND ASPIRINGeneric (ANDA)
ANDA 087794 · SUN PHARM INDUSTRIES
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.
