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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 073314


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NDA 073314 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 073314
Tradename:INDOMETHACIN
Applicant:Cosette
Ingredient:indomethacin
Patents:0
Pharmacology for NDA: 073314
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 073314
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INDOMETHACIN indomethacin SUPPOSITORY;RECTAL 073314 ANDA Zyla Life Sciences US LLC 69344-102 69344-102-33 30 SUPPOSITORY in 1 BOX (69344-102-33)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUPPOSITORY;RECTALStrength50MG
Approval Date:Aug 31, 1992TE:ABRLD:No

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