Orange Book product · Brand (NDA)
INDOMETHACIN
INDOMETHACIN
At a glance
Aug 06, 1984
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 06, 1984
42 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
INDOMETHACIN
Strength
50MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 018829
Product number
001
Marketing status
RX
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.
- 1984INDOMETHACINBrand (NDA)
NDA 018806 · PARKE DAVIS
- 1984INDOMETHACINBrand (NDA)
NDA 018851 · HERITAGE
- 1984INDOMETHACINBrand (NDA)
NDA 018730 · IVAX SUB TEVA PHARMS
- 1984INDOMETHACINBrand (NDA)
NDA 018858 · RISING
- 1982INDOCIN SRBrand (NDA)
NDA 018185 · ZYLA
- —INDOCINBrand (NDA)
NDA 016059 · ZYLA LIFE SCIENCES
- 2017INDOMETHACINGeneric (ANDA)
ANDA 202711 · ZYDUS PHARMS
- 2017INDOMETHACINGeneric (ANDA)
ANDA 205215 · JUBILANT GENERICS
- 2017INDOMETHACINGeneric (ANDA)
ANDA 203501 · GLENMARK PHARMS LTD
- 2017INDOMETHACINGeneric (ANDA)
ANDA 204853 · NOVAST LABS
- 2016INDOMETHACINGeneric (ANDA)
ANDA 204243 · AUROBINDO PHARMA
- 2015INDOMETHACINGeneric (ANDA)
ANDA 202706 · JUBILANT GENERICS
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.
