Product Details for NDA 211210
QMIIZ ODT (MELOXICAM)
7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: MELOXICAM
Proprietary Name: QMIIZ ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N211210
Product Number: 001
Approval Date: Oct 19, 2018
Applicant Holder Full Name: TERSERA THERAPEUTICS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
QMIIZ ODT (MELOXICAM)
Proprietary Name: QMIIZ ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N211210
Product Number: 001
Approval Date: Oct 19, 2018
Applicant Holder Full Name: TERSERA THERAPEUTICS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: MELOXICAM
Proprietary Name: QMIIZ ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N211210
Product Number: 002
Approval Date: Oct 19, 2018
Applicant Holder Full Name: TERSERA THERAPEUTICS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: QMIIZ ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N211210
Product Number: 002
Approval Date: Oct 19, 2018
Applicant Holder Full Name: TERSERA THERAPEUTICS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information