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Medtronic
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Federal Trade Commission
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Fuji

Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077928

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NDA 077928 describes MELOXICAM, which is a drug marketed by Anda Repository, Apotex Inc, Aurobindo Pharma, Breckenridge Pharm, Cipla Ltd, Cr Double Crane, Dr Reddys Labs Inc, Glenmark Generics, Impax Labs Inc, Lupin Pharms, Mylan, Puracap Pharm, Roxane, Strides Pharma, Sun Pharm Inds Inc, Taro, Teva Pharms, Unichem, Yabao Pharm, Yung Shin Pharm, and Zydus Pharms Usa, and is included in twenty-two NDAs. It is available from fifty-one suppliers. Additional details are available on the MELOXICAM profile page.

The generic ingredient in MELOXICAM is meloxicam. There are twenty-two drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the meloxicam profile page.
Summary for 077928
Tradename:MELOXICAM
Applicant:Strides Pharma
Ingredient:meloxicam
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 077928
Suppliers and Packaging for NDA: 077928
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MELOXICAM meloxicam TABLET;ORAL 077928 ANDA Apotex Corp 60505-3578 E 60505-3578-1
MELOXICAM meloxicam TABLET;ORAL 077928 ANDA Apotex Corp 60505-3578 E 60505-3578-5

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG
Approval Date:May 13, 2009TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:May 13, 2009TE:ABRLD:No

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