Orange Book product · Generic (ANDA)
IBUPROFEN
IBUPROFEN
At a glance
Sep 15, 2015
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 15, 2015
10 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
IBUPROFEN
Strength
400MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 091625
Product number
001
Marketing status
RX
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.
