Orange Book product · Brand (NDA)
CHILDREN'S ADVIL COLD
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
At a glance
Apr 18, 2002
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 18, 2002
24 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Strength
100MG/5ML;15MG/5ML
Dosage form
SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 021373
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2002ADVIL COLD AND SINUSBrand (NDA)
NDA 021374 · HALEON US HOLDINGS
- 2000CHILDREN'S MOTRIN COLDBrand (NDA)
NDA 021128 · KENVUE BRANDS
- 1992SINE-AID IBBrand (NDA)
NDA 019899 · KENVUE BRANDS
- 1989ADVIL COLD AND SINUSBrand (NDA)
NDA 019771 · HALEON US HOLDINGS
- 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.
