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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 211210


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NDA 211210 describes QMIIZ ODT, which is a drug marketed by Tersera Theraps Llc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the QMIIZ ODT profile page.

The generic ingredient in QMIIZ ODT is meloxicam. There are twenty-two drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the meloxicam profile page.
Summary for 211210
Tradename:QMIIZ ODT
Applicant:Tersera Theraps Llc
Ingredient:meloxicam
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 211210
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 211210
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QMIIZ ODT meloxicam TABLET, ORALLY DISINTEGRATING;ORAL 211210 NDA TerSera Therapeutics LLC 70720-115 70720-115-10 1 BLISTER PACK in 1 CARTON (70720-115-10) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
QMIIZ ODT meloxicam TABLET, ORALLY DISINTEGRATING;ORAL 211210 NDA TerSera Therapeutics LLC 70720-115 70720-115-99 10 BLISTER PACK in 1 CARTON (70720-115-99) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength7.5MG
Approval Date:Oct 19, 2018TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Aug 31, 2030Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength15MG
Approval Date:Oct 19, 2018TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Aug 31, 2030Product Flag?YSubstance Flag?Delist Request?

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