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Last Updated: June 21, 2024

Details for New Drug Application (NDA): 091608

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NDA 091608 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 091608
Ingredient:mefenamic acid
Formulation / Manufacturing:see details
Pharmacology for NDA: 091608
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 091608
Suppliers and Packaging for NDA: 091608
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEFENAMIC ACID mefenamic acid CAPSULE;ORAL 091608 ANDA Belcher Pharmaceuticals,LLC 62250-677 62250-677-30 30 CAPSULE in 1 BOTTLE (62250-677-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:Jun 2, 2014TE:ABRLD:No

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