Orange Book product · Brand (NDA)
REZIRA
HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE
At a glance
Jun 08, 2011
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 08, 2011
15 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Strength
5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 022442
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.
- 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 203839 · TRIS 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.
