Orange Book product · Generic (ANDA)
DISOBROM
DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE
Generic (ANDA)ANDA 070770DISCN SANDOZ
At a glance
Sep 30, 1991
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 30, 1991
35 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE
Strength
6MG;120MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
ANDA 070770
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE
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.
