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Last Updated: June 15, 2021

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Details for New Drug Application (NDA): 077927

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NDA 077927 describes MELOXICAM, which is a drug marketed by Lupin Ltd, Novitium Pharma, Anda Repository, Apotex Inc, Aurobindo Pharma, Cipla, Cr Double Crane, Dr Reddys Labs Inc, Glenmark Generics, Heritage Pharma, Impax Labs Inc, Lupin Pharms, Mylan, Nostrum Labs Inc, 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-four NDAs. It is available from thirty-eight 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-one suppliers are listed for this compound. Additional details are available on the meloxicam profile page.
Summary for 077927
Formulation / Manufacturing:see details
Pharmacology for NDA: 077927
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 077927
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MELOXICAM meloxicam TABLET;ORAL 077927 ANDA Unichem Pharmaceuticals (USA), Inc. 29300-124 29300-124-01 100 TABLET in 1 BOTTLE (29300-124-01)
MELOXICAM meloxicam TABLET;ORAL 077927 ANDA Unichem Pharmaceuticals (USA), Inc. 29300-124 29300-124-10 1000 TABLET in 1 BOTTLE (29300-124-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG
Approval Date:Dec 20, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Dec 20, 2006TE:ABRLD:No

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