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Last Updated: November 19, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077944

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NDA 077944 describes MELOXICAM, which is a drug marketed by Anda Repository, Apotex Inc, Aurobindo Pharma, Breckenridge Pharm, Cipla, Cr Double Crane, Dr Reddys Labs Inc, Glenmark Generics, Heritage Pharma, Impax Labs Inc, Lupin Pharms, Mylan, Puracap Pharm, Roxane, Strides Pharma, Sun Pharm Inds Inc, Taro, Unichem, Yabao Pharm, Yung Shin Pharm, and Zydus Pharms Usa, and is included in twenty-two NDAs. It is available from forty-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. Forty-five suppliers are listed for this compound. Additional details are available on the meloxicam profile page.
Summary for 077944
Applicant:Lupin Pharms
Formulation / Manufacturing:see details
Pharmacology for NDA: 077944
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 077944
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MELOXICAM meloxicam TABLET;ORAL 077944 ANDA Bryant Ranch Prepack 63629-6707 63629-6707-1 60 TABLET in 1 BOTTLE (63629-6707-1)
MELOXICAM meloxicam TABLET;ORAL 077944 ANDA Bryant Ranch Prepack 63629-6707 63629-6707-2 30 TABLET in 1 BOTTLE (63629-6707-2)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG
Approval Date:Jul 19, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Jul 19, 2006TE:ABRLD:No

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