Orange Book product · Generic (ANDA)
IBUPROFEN
IBUPROFEN
At a glance
Sep 26, 2018
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 26, 2018
7 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
IBUPROFEN
Strength
40MG/ML
Dosage form
SUSPENSION/DROPS
Route
ORAL
TE code
Not listed
Application
ANDA 210755
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of IBUPROFEN
- 2009CALDOLORBrand (NDA)
NDA 022348 · CUMBERLAND PHARMS
- 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
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.
