Orange Book product · Generic (ANDA)
INDOMETHACIN
INDOMETHACIN
At a glance
Jul 03, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 03, 2025
1 yr ago
Today
Pharmaceutical detail
Active ingredient
INDOMETHACIN
Strength
50MG
Dosage form
SUPPOSITORY
Route
RECTAL
TE code
AB
Application
ANDA 216905
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of INDOMETHACIN
- 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.
