Orange Book product · Brand (NDA)
INFANT'S ADVIL
IBUPROFEN
At a glance
Jan 12, 2000
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 12, 2000
26 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
IBUPROFEN
Strength
50MG/1.25ML
Dosage form
SUSPENSION/DROPS
Route
ORAL
TE code
Not listed
Application
NDA 020812
Product number
002
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.
- 2009CALDOLORBrand (NDA)
NDA 022348 · CUMBERLAND PHARMS
- 2004CHILDREN'S ELIXSUREBrand (NDA)
NDA 021604 · MOBERG PHARMA NORTH
- 2002MIDOL LIQUID GELSBrand (NDA)
NDA 021472 · BIONPHARMA
- 1998CHILDREN'S ADVILBrand (NDA)
NDA 020944 · HALEON US HOLDINGS
- 1996CHILDREN'S MOTRINBrand (NDA)
NDA 020601 · KENVUE BRANDS
- 1996CHILDREN'S ADVILBrand (NDA)
NDA 020589 · HALEON US HOLDINGS
- 1996CHILDREN'S MOTRINBrand (NDA)
NDA 020603 · KENVUE BRANDS
- 1995CHILDREN'S MOTRINBrand (NDA)
NDA 020516 · KENVUE BRANDS
- 1995MOTRINBrand (NDA)
NDA 020476 · MCNEIL
- 1995ADVIL LIQUI-GELSBrand (NDA)
NDA 020402 · HALEON US HOLDINGS
- 1989IBUBrand (NDA)
NDA 019784 · ABBOTT
- 1989CHILDREN'S ADVILBrand (NDA)
NDA 019833 · HALEON US HOLDINGS
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.
