Orange Book product · Brand (NDA)
INDOCIN
INDOMETHACIN
At a glance
Aug 13, 1984
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 13, 1984
42 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
INDOMETHACIN
Strength
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SUPPOSITORY
Route
RECTAL
TE code
Not listed
Application
NDA 017814
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 1984INDOMETHACINBrand (NDA)
NDA 018806 · PARKE DAVIS
- 1984INDOMETHACINBrand (NDA)
NDA 018829 · CHARTWELL MOLECULES
- 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
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.
