Orange Book product · Brand (NDA)
ADVIL COLD AND SINUS
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
At a glance
Sep 19, 1989
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 19, 1989
37 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Strength
200MG;30MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 019771
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2002ADVIL COLD AND SINUSBrand (NDA)
NDA 021374 · HALEON US HOLDINGS
- 2002CHILDREN'S ADVIL COLDBrand (NDA)
NDA 021373 · HALEON US HOLDINGS
- 2000CHILDREN'S MOTRIN COLDBrand (NDA)
NDA 021128 · KENVUE BRANDS
- 1992SINE-AID IBBrand (NDA)
NDA 019899 · KENVUE BRANDS
- 2023IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 213565 · AUROBINDO PHARMA LTD
- 2017IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 209235 · AUROBINDO PHARMA
- 2006IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 077628 · STRIDES PHARMA
- 2003IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 076478 · PERRIGO
- 2002IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 075588 · CONTRACT PHARMACAL
- 2001IBUPROHM COLD AND SINUSGeneric (ANDA)
ANDA 074567 · OHM LABS
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.
