Orange Book product · Brand (NDA)
CHLOR-TRIMETON
CHLORPHENIRAMINE 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
CHLORPHENIRAMINE MALEATE
Strength
8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 007638
Product number
001
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.
- 1994EFIDAC 24 CHLORPHENIRAMINE MALEATEBrand (NDA)
NDA 019746 · ALZA
- —TELDRINBrand (NDA)
NDA 017369 · GLAXOSMITHKLINE
- —CHLOR-TRIMETONBrand (NDA)
NDA 008826 · SCHERING PLOUGH
- —CHLOR-TRIMETONBrand (NDA)
NDA 008794 · SCHERING PLOUGH
- —CHLOR-TRIMETONBrand (NDA)
NDA 006921 · SCHERING
- 2009CHLORPHENIRAMINE MALEATEGeneric (ANDA)
ANDA 040829 · AVANTHI INC
- 1988CHLORPHENIRAMINE MALEATEGeneric (ANDA)
ANDA 070797 · AUROLIFE PHARMA LLC
- 1984CHLORPHENIRAMINE MALEATEGeneric (ANDA)
ANDA 088556 · PIONEER PHARMS
- 1982CHLORPHENIRAMINE MALEATEGeneric (ANDA)
ANDA 087520 · PHARM ASSOC
- —CHLORPHENIRAMINE MALEATEGeneric (ANDA)
ANDA 080821 · BEL MAR
- —CHLORPHENIRAMINE MALEATEGeneric (ANDA)
ANDA 080797 · ELKINS SINN
- —CHLORPHENIRAMINE MALEATEGeneric (ANDA)
ANDA 083593 · WATSON LABS
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.
