Orange Book product · Brand (NDA)
CALDOLOR
IBUPROFEN
At a glance
Jun 11, 2009
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 11, 2009
17 yr 3 mo ago
Exclusivity ends · NPP
New patient population exclusivity (3 years)
May 11, 2026
1 mo ago
Today
Pharmaceutical detail
Active ingredient
IBUPROFEN
Strength
400MG/4ML (100MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 022348
Product number
001
Marketing status
DISCN
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.
- 2004CHILDREN'S ELIXSUREBrand (NDA)
NDA 021604 · MOBERG PHARMA NORTH
- 2002MIDOL LIQUID GELSBrand (NDA)
NDA 021472 · BIONPHARMA
- 2000INFANT'S ADVILBrand (NDA)
NDA 020812 · HALEON US HOLDINGS
- 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
Marketing exclusivity (1)
- NPPNew patient population exclusivity (3 years)
May 11, 2026
1 mo ago
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.
