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July 13, 2016
Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Isoniazid isoniazid Tablet;Oral Sandoz Labeling Revision
Morphine Sulfate morphine sulfate Solution;Oral Rhodes Pharms Approval
Rozerem ramelteon Tablet;Oral Takeda Pharms Usa Manufacturing Change or Addition
Smoflipid soybean;mct;olive;fish Injectable, Lipid Complex;Injection Fresenius Kabi Usa Approval
Thallous Chloride Tl 201 thallous chloride tl-201 Injectable;Injection Mallinkrodt Nuclear Labeling Revision
July 12, 2016
Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Amlodipine Besylate amlodipine besylate Tablet;Oral Polygen Pharms Approval
Asmanex Hfa mometasone furoate Aerosol, Metered;Inhalation Merck Sharp Dohme Efficacy Supplement with Clinical Data to Support
Cialis tadalafil Tablet;Oral Lilly Manufacturing Change or Addition
Cymbalta duloxetine hydrochloride Capsule, Delayed Rel Pellets;Oral Lilly Manufacturing Change or Addition
Dulera formoterol fumarate; mometasone furoate Aerosol, Metered;Inhalation Merck Sharp Dohme Efficacy Supplement with Clinical Data to Support
Effient prasugrel hydrochloride Tablet;Oral Eli Lilly and Co Efficacy Supplement with Clinical Data to Support
Faslodex fulvestrant Injectable;Intramuscular Astrazeneca Labeling Revision
Fenofibrate fenofibrate Tablet;Oral Hetero Labs Ltd Iii Approval
Tarka trandolapril; verapamil hydrochloride Tablet, Extended Release;Oral Abbvie Labeling Revision
July 11, 2016
Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Alinia nitazoxanide Tablet;Oral Romark Labeling Revision
Alinia nitazoxanide For Suspension;Oral Romark Labeling Revision
Brovana arformoterol tartrate Solution;Inhalation Sunovion Manufacturing Change or Addition
Furadantin nitrofurantoin Suspension;Oral Shionogi Inc Manufacturing Change or Addition
Gatifloxacin gatifloxacin Solution/Drops;Ophthalmic Alcon Res Ltd Approval
Juxtapid lomitapide mesylate Capsule;Oral Aegerion Manufacturing Change or Addition
Metformin Hydrochloride metformin hydrochloride Tablet;Oral Cspc Ouyi Pharm Co Approval
Vilazodone Hydrochloride vilazodone hydrochloride Tablet;Oral Teva Pharms Usa Tentative Approval
Xiidra lifitegrast Solution/Drops; Ophthalmic Shire Dev Llc Approval
July 8, 2016
Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Absorica isotretinoin Capsule;Oral Ranbaxy Supplement
Azor amlodipine besylate; olmesartan medoxomil Tablet;Oral Daiichi Sankyo Manufacturing Change or Addition
Benicar olmesartan medoxomil Tablet;Oral Daiichi Sankyo Manufacturing Change or Addition
Dexilant dexlansoprazole Capsule, Delayed Release;Oral Takeda Pharms Usa Efficacy Supplement with Clinical Data to Support
Dexilant Solutab dexlansoprazole Tablet, Orally Disintegrating, Delayed Release;Oral Takeda Pharms Usa Labeling Revision
Differin adapalene Gel;Topical Galderma Labs Lp Efficacy Supplement with Clinical Data to Support
Duexis famotidine; ibuprofen Tablet;Oral Horizon Pharma Manufacturing Change or Addition
Femcon Fe ethinyl estradiol; norethindrone Tablet, Chewable;Oral Apil Manufacturing Change or Addition
Glyxambi empagliflozin; linagliptin Tablet;Oral Boehringer Ingelheim Labeling Revision
Hicon sodium iodide i-131 Solution;Oral Jubilant Draximage Labeling Revision
Humulin R insulin human Solution;Subcutaneous Lilly Labeling Revision
Humulin R insulin recombinant human Injectable;Injection Lilly Labeling Revision
Humulin R Kwikpen insulin human Solution;Subcutaneous Lilly Labeling Revision
Humulin R Pen insulin recombinant human Injectable;Injection Lilly Labeling Revision
Idkit:hp citric acid; urea c-13 For Solution, Tablet, For Solution;Oral Exalenz Bioscience Manufacturing Change or Addition
Jardiance empagliflozin Tablet;Oral Boehringer Ingelheim Labeling Revision
Lamprene clofazimine Capsule;Oral Novartis Labeling Revision
Latuda lurasidone hydrochloride Tablet;Oral Sunovion Pharms Inc Manufacturing Change or Addition
Lyrica pregabalin Capsule;Oral Pf Prism Cv Manufacturing Change or Addition
Menopur menotropins (fsh;lh) Injectable;Subcutaneous Ferring Manufacturing Change or Addition
Omidria ketorolac tromethamine; phenylephrine hydrochloride Solution;Irrigation Omeros Manufacturing Change or Addition
Pentetate Calcium Trisodium pentetate calcium trisodium Solution;Inhalation, Intravenous Hameln Pharma Plus Manufacturing Change or Addition
Repatha evolocumab Injectable;Injection Amgen Inc Efficacy Supplement with Clinical Data to Support
Repatha evolocumab Injectable;Injection Amgen Inc Labeling Revision
Sodium Iodide I 131 sodium iodide i-131 Capsule;Oral Jubilant Draximage Labeling Revision
Synjardy empagliflozin; metformin hydrochloride Tablet;Oral Boehringer Ingelheim Efficacy Supplement with Clinical Data to Support
Synjardy empagliflozin; metformin hydrochloride Tablet;Oral Boehringer Ingelheim Labeling Revision
Tegretol carbamazepine Suspension;Oral Novartis Manufacturing Change or Addition
Tresiba insulin degludec Solution;Subcutaneous Novo Nordisk Inc Manufacturing Change or Addition
Veregen sinecatechins Ointment;Topical Medigene Ag Manufacturing Change or Addition
July 7, 2016
Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Bunavail buprenorphine hydrochloride; naloxone hydrochloride Film;Buccal Biodelivery Sci Intl Supplement
Cerezyme imiglucerase Injectable;Injection Genzyme Manufacturing Change or Addition
Hydromorphone Hydrochloride hydromorphone hydrochloride Tablet, Extended Release;Oral Osmotica Approval
Intuniv guanfacine hydrochloride Tablet, Extended Release;Oral Shire Labeling Revision
Mili ethinyl estradiol; norgestimate Tablet;Oral-28 Aurobindo Pharma Ltd Approval
Suboxone buprenorphine hydrochloride; naloxone hydrochloride Tablet;Sublingual Indivior Inc Supplement
Suboxone buprenorphine hydrochloride; naloxone hydrochloride Film;Buccal, Sublingual Indivior Inc Supplement
Subutex buprenorphine hydrochloride Tablet;Sublingual Indivior Inc Supplement
Triamcinolone Acetonide triamcinolone acetonide Lotion;Topical Teligent Pharma Inc Approval
Triamcinolone Acetonide triamcinolone acetonide Lotion;Topical Teligent Pharma Inc Approval
Zubsolv buprenorphine hydrochloride; naloxone hydrochloride Tablet;Sublingual Orexo Ab Supplement
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Page Last Updated: 07/14/2016
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