Orange Book product · Generic (ANDA)
HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE
HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE
At a glance
Oct 28, 2014
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 28, 2014
11 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Strength
5MG/5ML;60MG/5ML
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
ANDA 203839
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE
- 2011REZIRABrand (NDA)
NDA 022442 · PERSION
- 2019HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 206661 · SCIEGEN PHARMS
- 2015HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 205658 · MAYNE PHARMA INC
- 2014HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 204658 · 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.
