Orange Book product · Brand (NDA)
CODEINE SULFATE
CODEINE SULFATE
Brand (NDA)NDA 022402TE ABRX HIKMA
At a glance
Jul 16, 2009
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 16, 2009
17 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
CODEINE SULFATE
Strength
15MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 022402
Product number
001
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.
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.
