Orange Book product · Generic (ANDA)
PSEUDOEPHEDRINE HYDROCHLORIDE
PSEUDOEPHEDRINE HYDROCHLORIDE
At a glance
Dec 29, 2025
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 29, 2025
6 mo ago
Today
Pharmaceutical detail
Active ingredient
PSEUDOEPHEDRINE HYDROCHLORIDE
Strength
240MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
ANDA 218854
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of PSEUDOEPHEDRINE HYDROCHLORIDE
- 1992SUDAFED 24 HOURBrand (NDA)
NDA 020021 · KENVUE BRANDS
- —NOVAFEDBrand (NDA)
NDA 017603 · SANOFI AVENTIS US
- —SUDAFED 12 HOURBrand (NDA)
NDA 017941 · GLAXOSMITHKLINE
- 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.
