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Last Updated: May 13, 2021

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Details for New Drug Application (NDA): 091276

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NDA 091276 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, Cosette, Hikma, Hospira Inc, Navinta Llc, and West-ward Pharms Int, and is included in sixty-two NDAs. It is available from twenty-nine 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 091276
Applicant:Glenmark Generics
Formulation / Manufacturing:see details
Pharmacology for NDA: 091276
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 091276
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INDOMETHACIN indomethacin CAPSULE;ORAL 091276 ANDA Lake Erie Medical DBA Quality Care Products LLC 35356-697 35356-697-15 15 CAPSULE in 1 BOTTLE (35356-697-15)
INDOMETHACIN indomethacin CAPSULE;ORAL 091276 ANDA Lake Erie Medical DBA Quality Care Products LLC 35356-697 35356-697-30 30 CAPSULE in 1 BOTTLE (35356-697-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Dec 22, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Dec 22, 2010TE:ABRLD:No

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