Orange Book product · Generic (ANDA)
HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE
CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE
At a glance
May 15, 2017
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 15, 2017
9 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Strength
4MG/5ML;5MG/5ML;60MG/5ML
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
ANDA 206660
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE
- 2011ZUTRIPROBrand (NDA)
NDA 022439 · PERSION
- 2015HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 205657 · MAYNE PHARMA INC
- 2014HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 203838 · TRIS PHARMA INC
- 2014HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 204627 · PADAGIS US
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.
