Orange Book product · Brand (NDA)
DRIXORAL
DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE
At a glance
Sep 13, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 13, 1982
44 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE
Strength
6MG;120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 013483
Product number
003
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.
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.
