Orange Book product · Brand (NDA)
SUDAFED 12 HOUR
PSEUDOEPHEDRINE HYDROCHLORIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
PSEUDOEPHEDRINE HYDROCHLORIDE
Strength
120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 017941
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.
- 1992SUDAFED 24 HOURBrand (NDA)
NDA 020021 · KENVUE BRANDS
- —NOVAFEDBrand (NDA)
NDA 017603 · SANOFI AVENTIS US
- 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.
