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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 018829


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NDA 018829 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, Mylan, Novast Labs, Sandoz, Watson Labs Inc, Zydus Pharms, Ani Pharms, Chartwell Molecules, Cycle, Duramed Pharms Barr, Halsey, Heritage, Heritage Pharma, Ivax Sub Teva Pharms, Mutual Pharm, Parke Davis, Pioneer Pharms, Rising, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, Teva, Watson Labs, Zydus Lifesciences, Fresenius Kabi Usa, Cosette, 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. Additional details are available on the indomethacin sodium profile page.
Summary for 018829
Tradename:INDOMETHACIN
Applicant:Chartwell Molecules
Ingredient:indomethacin
Patents:0
Pharmacology for NDA: 018829
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 018829
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INDOMETHACIN indomethacin CAPSULE;ORAL 018829 NDA Chartwell RX, LLC 62135-067 62135-067-18 180 CAPSULE in 1 BOTTLE (62135-067-18)
INDOMETHACIN indomethacin CAPSULE;ORAL 018829 NDA Chartwell RX, LLC 62135-067 62135-067-90 90 CAPSULE in 1 BOTTLE (62135-067-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Aug 6, 1984TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Aug 6, 1984TE:ABRLD:No

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