Orange Book product · Brand (NDA)
DIMETANE
BROMPHENIRAMINE MALEATE
At a glance
Jun 10, 1983
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 10, 1983
43 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
BROMPHENIRAMINE MALEATE
Strength
8MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 010799
Product number
010
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.
- —DIMETANE-TENBrand (NDA)
NDA 011418 · WYETH AYERST
- 1984BROMPHENIRAMINE MALEATEGeneric (ANDA)
ANDA 088604 · PIONEER PHARMS
- 1983BROMPHENIRAMINE MALEATEGeneric (ANDA)
ANDA 087964 · USL PHARMA
- —BROMPHENIRAMINE MALEATEGeneric (ANDA)
ANDA 086936 · ALPHARMA US PHARMS
- —BROMPHENIRAMINE MALEATEGeneric (ANDA)
ANDA 085466 · KV PHARM
- —BROMPHENIRAMINE MALEATEGeneric (ANDA)
ANDA 087517 · PHARM ASSOC
- —BROMPHENIRAMINE MALEATEGeneric (ANDA)
ANDA 083821 · WATSON LABS
- —BROMPHENIRAMINE MALEATEGeneric (ANDA)
ANDA 083820 · WATSON LABS
- —BROMPHENIRAMINE MALEATEGeneric (ANDA)
ANDA 084468 · BARR
- —BROMPHENIRAMINE MALEATEGeneric (ANDA)
ANDA 084351 · IVAX SUB TEVA PHARMS
- —BROMPHENIRAMINE MALEATEGeneric (ANDA)
ANDA 086987 · NEWTRON PHARMS
- —BROMPHENIRAMINE MALEATEGeneric (ANDA)
ANDA 086187 · NEXGEN PHARMA INC
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.
