Details for New Drug Application (NDA): 091322
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NDA 091322 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 six 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. Six suppliers are listed for this compound. 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. Six suppliers are listed for this compound. Additional details are available on the mefenamic acid profile page.
Summary for 091322
| Tradename: | MEFENAMIC ACID |
| Applicant: | Lupin Ltd |
| Ingredient: | mefenamic acid |
| Patents: | 0 |
Pharmacology for NDA: 091322
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 091322
Suppliers and Packaging for NDA: 091322
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MEFENAMIC ACID | mefenamic acid | CAPSULE;ORAL | 091322 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-185 | 68180-185-06 | 30 CAPSULE in 1 BOTTLE (68180-185-06) |
| MEFENAMIC ACID | mefenamic acid | CAPSULE;ORAL | 091322 | ANDA | Advanced Rx of Tennessee, LLC | 80425-0423 | 80425-0423-1 | 30 CAPSULE in 1 BOTTLE (80425-0423-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 250MG | ||||
| Approval Date: | Jul 22, 2011 | TE: | AB | RLD: | No | ||||
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