The United States Food and Drug Administration

New and Generic Drug Approvals

October 21, 2015

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Breo Ellipta fluticasone furoate; vilanterol trifenatate Powder;Inhalation Glaxo Grp Ltd Manufacturing Change or Addition
Chorionic Gonadotropin gonadotropin, chorionic Injectable;Injection Ferring Manufacturing Change or Addition
Claritin loratadine Syrup;Oral Bayer Healthcare Llc Manufacturing Change or Addition
Claritin Hives Relief loratadine Syrup;Oral Bayer Healthcare Llc Manufacturing Change or Addition
Dexmedetomidine Hydrochloride dexmedetomidine hydrochloride Injectable;Injection Hq Speciality Pharma Approval
Docetaxel docetaxel Injectable;Injection Accord Hlthcare Manufacturing Change or Addition
Omnipaque 140 iohexol Injectable;Injection Ge Healthcare Manufacturing Change or Addition
Omnipaque 180 iohexol Solution;Injection, Oral, Rectal Ge Healthcare Manufacturing Change or Addition
Omnipaque 210 iohexol Injectable;Injection Ge Healthcare Manufacturing Change or Addition
Omnipaque 240 iohexol Solution;Injection, Oral, Rectal Ge Healthcare Manufacturing Change or Addition
Omnipaque 300 iohexol Solution;Injection, Oral, Rectal Ge Healthcare Manufacturing Change or Addition
Omnipaque 350 iohexol Solution;Injection, Oral Ge Healthcare Manufacturing Change or Addition
Omnipaque 70 iohexol Solution;Urethral Ge Healthcare Manufacturing Change or Addition
Veltassa patiromer Powder;Oral Relypsa Inc Approval

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Download Access Links to the FDA Approvals

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Last Updated: 2015-10-23

FDA New and Generic Drug Approvals – 21 October 2015
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