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Last Updated: April 19, 2024

Details for New Drug Application (NDA): 090562


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NDA 090562 describes MEFENAMIC ACID, which is a drug marketed by Belcher, Chartwell Rx, Lupin Ltd, Micro Labs, and Nostrum Labs Inc, and is included in five NDAs. It is available from four suppliers. Additional details are available on the MEFENAMIC ACID profile page.

The generic ingredient in MEFENAMIC ACID is mefenamic acid. There are thirteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the mefenamic acid profile page.
Summary for 090562
Tradename:MEFENAMIC ACID
Applicant:Micro Labs
Ingredient:mefenamic acid
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090562
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 090562
Suppliers and Packaging for NDA: 090562
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEFENAMIC ACID mefenamic acid CAPSULE;ORAL 090562 ANDA Micro Labs Limited 42571-258 42571-258-01 100 CAPSULE in 1 BOTTLE (42571-258-01)
MEFENAMIC ACID mefenamic acid CAPSULE;ORAL 090562 ANDA Micro Labs Limited 42571-258 42571-258-30 30 CAPSULE in 1 BOTTLE (42571-258-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:Nov 19, 2010TE:ABRLD:No

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