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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 072996


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NDA 072996 describes INDOMETHACIN, which is a drug marketed by Able, Amneal Pharms, Aurobindo Pharma, Avanthi Inc, Chartwell Rx, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Inwood Labs, Jubilant Generics, Novast Labs, Rising, Sandoz, Watson Labs Inc, Zydus Pharms, Ani Pharms, Chartwell Molecules, Cycle, Duramed Pharms Barr, Glenmark Generics, Halsey, Heritage Pharma, Heritage Pharms, Ivax Sub Teva Pharms, Mutual Pharm, Parke Davis, Pioneer Pharms, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, Teva, Watson Labs, Zydus Lifesciences, Fresenius Kabi Usa, Cosette, Zydus, Hikma, Novitium Pharma, Hospira, Navinta Llc, and West-ward Pharms Int, and is included in sixty-four NDAs. It is available from thirty-two suppliers. Additional details are available on the INDOMETHACIN profile page.

The generic ingredient in INDOMETHACIN is indomethacin sodium. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the indomethacin sodium profile page.
Summary for 072996
Tradename:INDOMETHACIN
Applicant:Watson Labs
Ingredient:indomethacin
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength25MG
Approval Date:Jul 31, 1991TE:RLD:No

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