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Last Updated: August 11, 2020

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Details for New Drug Application (NDA): 079175

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NDA 079175 describes INDOMETHACIN, which is a drug marketed by Able, Amneal Pharms, Aurobindo Pharma Ltd, 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 Inc, Cadila, Chartwell Molecules, Cycle Pharms Ltd, Duramed Pharms Barr, Glenmark Generics, Halsey, Heritage, Heritage Pharma, Ivax Sub Teva Pharms, Mutual Pharm, Parke Davis, Pioneer Pharms, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, Teva, Watson Labs, Fresenius Kabi Usa, Acp Nimble, Hikma, Hospira Inc, Navinta Llc, and West-ward Pharms Int, and is included in sixty-two NDAs. It is available from thirty-one 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. Two suppliers are listed for this compound. Additional details are available on the indomethacin sodium profile page.
Summary for 079175
Tradename:INDOMETHACIN
Applicant:Avanthi Inc
Ingredient:indomethacin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 079175
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 079175
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INDOMETHACIN indomethacin CAPSULE, EXTENDED RELEASE;ORAL 079175 ANDA KVK-Tech, Inc. 10702-016 10702-016-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10702-016-01)
INDOMETHACIN indomethacin CAPSULE, EXTENDED RELEASE;ORAL 079175 ANDA KVK-Tech, Inc. 10702-016 10702-016-03 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10702-016-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength75MG
Approval Date:Mar 6, 2009TE:ABRLD:No

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