Orange Book product · Brand (NDA)
INDOCIN
INDOMETHACIN
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
INDOMETHACIN
Strength
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 016059
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
- 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.
