Orange Book product · Brand (NDA)
DIMETANE-TEN
BROMPHENIRAMINE MALEATE
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
BROMPHENIRAMINE MALEATE
Strength
10MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 011418
Product number
002
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.
- 1983DIMETANEBrand (NDA)
NDA 010799 · WYETH CONS
- 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.
