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Details for New Drug Application (NDA): 077937

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NDA 077937 describes MELOXICAM, which is a drug marketed by Taro, Aurobindo Pharma, Carlsbad, Breckenridge Pharm, Zydus Pharms Usa, Mylan, Roxane, Unichem, Strides Pharma, Cipla Ltd, Corepharma, Dr Reddys Labs Inc, Glenmark Generics, Yabao Pharm, Frontida Biopharm, Teva Pharms, Sun Pharm Inds Inc, Puracap Pharm, Cr Double Crane, Lupin Pharms, and Apotex Inc, and is included in twenty-two NDAs. It is available from fifty-three 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-six suppliers are listed for this compound. Additional details are available on the meloxicam profile page.

Summary for NDA: 077937

Tradename:
MELOXICAM
Applicant:
Sun Pharm Inds Inc
Ingredient:
meloxicam
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077937

Suppliers and Packaging for NDA: 077937

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MELOXICAM
meloxicam
TABLET;ORAL 077937 ANDA STAT Rx USA LLC 42549-519 42549-519-12 120 TABLET in 1 BOTTLE (42549-519-12)
MELOXICAM
meloxicam
TABLET;ORAL 077937 ANDA STAT Rx USA LLC 42549-519 42549-519-30 30 TABLET in 1 BOTTLE (42549-519-30)

Summary for product number 001

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

Summary for product number 002

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


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