Orange Book product · Brand (NDA)
PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE
CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
At a glance
Aug 02, 1988
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 02, 1988
38 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Strength
8MG;120MG
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 019428
Product number
001
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.
- 1986ISOCLORBrand (NDA)
NDA 018747 · FISONS
- 1985CODIMAL-L.A. 12Brand (NDA)
NDA 018935 · SCHWARZ PHARMA
- 1985PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATEBrand (NDA)
NDA 018844 · GRAHAM DM
- 1985PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATEBrand (NDA)
NDA 018843 · GRAHAM DM
- 1989PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATEGeneric (ANDA)
ANDA 071455 · KV PHARM
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.
