Orange Book product · Brand (NDA)
SUDAFED 24 HOUR
PSEUDOEPHEDRINE HYDROCHLORIDE
At a glance
Dec 15, 1992
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 15, 1992
34 yr ago
Today
Pharmaceutical detail
Active ingredient
PSEUDOEPHEDRINE HYDROCHLORIDE
Strength
240MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 020021
Product number
002
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.
- —NOVAFEDBrand (NDA)
NDA 017603 · SANOFI AVENTIS US
- —SUDAFED 12 HOURBrand (NDA)
NDA 017941 · GLAXOSMITHKLINE
- 2025PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218854 · AUROBINDO PHARMA LTD
- 2017PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 209008 · AUROBINDO PHARMA
- 2005PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 077442 · SUN PHARM INDS LTD
- 1999PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 075153 · L PERRIGO CO
- 1991SUDAFED 12 HOURGeneric (ANDA)
ANDA 073585 · MCNEIL CONS
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.
