April 9, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Levonorgestrel and Ethinyl Estradiol | ethinyl estradiol; levonorgestrel | Tablet;Oral | Glenmark Generics | Approval |
| Rifadin | rifampin | Injectable;Injection | Sanofi Aventis Us | Manufacturing Change or Addition |
| Testim | testosterone | Gel;Transdermal | Auxilium Pharms | Manufacturing Change or Addition |
April 8, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Actonel | risedronate sodium | Tablet;Oral | Warner Chilcott Llc | Labeling Revision |
| Actonel With Calcium (Copackaged) | calcium carbonate; risedronate sodium | Tablet, Tablet;Oral | Warner Chilcott | Labeling Revision |
| Atelvia | risedronate sodium | Tablet, Delayed Release;Oral | Warner Chilcott Llc | Labeling Revision |
| Atracurium Besylate | atracurium besylate | Injectable;Injection | Aurobindo Pharma Ltd | Approval |
| Atracurium Besylate Preservative Free | atracurium besylate | Injectable;Injection | Aurobindo Pharma Ltd | Approval |
| Binosto | alendronate sodium | Tablet, Effervescent;Oral | Mission Pharma | Labeling Revision |
| Boniva | ibandronate sodium | Tablet;Oral | Hoffmann La Roche | Labeling Revision |
| Boniva | ibandronate sodium | Injectable;Intravenous | Roche | Labeling Revision |
| Didronel | etidronate disodium | Tablet;Oral | Procter and Gamble | Labeling Revision |
| Fosamax | alendronate sodium | Tablet;Oral | Merck and Co Inc | Labeling Revision |
| Fosamax | alendronate sodium | Solution;Oral | Merck | Labeling Revision |
| Fosamax Plus D | alendronate sodium; cholecalciferol | Tablet;Oral | Merck | Labeling Revision |
| Mannitol 10% | mannitol | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Mannitol 15% | mannitol | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Mannitol 20% | mannitol | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Mannitol 25% | mannitol | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Mannitol 5% | mannitol | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Osmitrol 10% In Water | mannitol | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Osmitrol 10% In Water In Plastic Container | mannitol | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Osmitrol 15% In Water | mannitol | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Osmitrol 15% In Water In Plastic Container | mannitol | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Osmitrol 20% In Water | mannitol | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Osmitrol 20% In Water In Plastic Container | mannitol | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Osmitrol 5% In Water | mannitol | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Osmitrol 5% In Water In Plastic Container | mannitol | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Procysbi | cysteamine bitartrate | Capsule, Delayed Release;Oral | Raptor Inc | Manufacturing Change or Addition |
| Prolia | denosumab | Injectable; Subcutaneous | Amgen | Labeling Revision |
| Valacyclovir Hydrochloride | valacyclovir hydrochloride | Tablet;Oral | Hetero Labs Ltd V | Approval |
| Xgeva | denosumab | Injectable; Subcutaneous | Amgen | Labeling Revision |
April 7, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Advil Pm | diphenhydramine citrate; ibuprofen | Tablet;Oral | Pfizer | Manufacturing Change or Addition |
| Bactrim | sulfamethoxazole; trimethoprim | Tablet;Oral | Mutual Pharm | Manufacturing Change or Addition |
| Bactrim Ds | sulfamethoxazole; trimethoprim | Tablet;Oral | Mutual Pharm | Manufacturing Change or Addition |
| Besivance | besifloxacin hydrochloride | Suspension/Drops;Ophthalmic | Bausch and Lomb | Manufacturing Change or Addition |
| Clobex | clobetasol propionate | Spray;Topical | Galderma Labs Lp | Manufacturing Change or Addition |
| Cosmegen | dactinomycin | Injectable;Injection | Recordati Rare | Manufacturing Change or Addition |
| Dacogen | decitabine | Injectable;Intravenous | Otsuka Pharm Co Ltd | Manufacturing Change or Addition |
| Docetaxel | docetaxel | Injectable;Injection | Actavis Inc | Manufacturing Change or Addition |
| Ella | ulipristal acetate | Tablet;Oral | Lab Hra Pharma | Manufacturing Change or Addition |
| Fludeoxyglucose F18 | fludeoxyglucose f-18 | Injectable;Intravenous | Precision Nuclear | Approval |
| Lidocaine Hydrochloride 0.1% and Dextrose 5% In Plastic Container | lidocaine hydrochloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Lidocaine Hydrochloride 0.2% and Dextrose 5% In Plastic Container | lidocaine hydrochloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Lidocaine Hydrochloride 0.4% and Dextrose 5% In Plastic Container | lidocaine hydrochloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Lidocaine Hydrochloride 0.8% and Dextrose 5% In Plastic Container | lidocaine hydrochloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Loseasonique | ethinyl estradiol; levonorgestrel | Tablet;Oral | Teva Branded Pharm | Manufacturing Change or Addition |
| Maxidex | dexamethasone | Suspension/Drops;Ophthalmic | Alcon | Manufacturing Change or Addition |
| Mucinex Dm | dextromethorphan hydrobromide; guaifenesin | Tablet, Extended Release;Oral | Reckitt Benckiser | Manufacturing Change or Addition |
| Norgestimate and Ethinyl Estradiol | ethinyl estradiol; norgestimate | Tablet;Oral-28 | Oc Pharma | Approval |
| Norgestimate and Ethinyl Estradiol | ethinyl estradiol; norgestimate | Tablet;Oral-28 | Oc Pharma | Approval |
| Pradaxa | dabigatran etexilate mesylate | Capsule;Oral | Boehringer Ingelheim | Manufacturing Change or Addition |
| Promacta | eltrombopag olamine | Tablet;Oral | Glaxosmithkline | Labeling Revision |
| Sodium Chloride 0.45% In Plastic Container | sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Sodium Chloride 0.9% In Plastic Container | sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Sodium Chloride 3% In Plastic Container | sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Sodium Chloride 5% In Plastic Container | sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Stribild | cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate | Tablet;Oral | Gilead Sciences Inc | Manufacturing Change or Addition |
| Stromectol | ivermectin | Tablet;Oral | Merck Sharp Dohme | Manufacturing Change or Addition |
| Zecuity | sumatriptan succinate | System;Iontophoresis | Teva Branded Pharm | Manufacturing Change or Addition |
April 6, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Adapalene and Benzoyl Peroxide | adapalene; benzoyl peroxide | Gel;Topical | Actavis Mid Atlantic | Tentative Approval |
| Hydromorphone Hydrochloride | hydromorphone hydrochloride | Tablet, Extended Release;Oral | Paddock Llc | Approval |
| Morphine Sulfate | morphine sulfate | Tablet, Extended Release;Oral | Actavis Elizabeth | Approval |
April 3, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Amlodipine Besylate and Valsartan | amlodipine besylate; valsartan | Tablet;Oral | Alembic Pharms Ltd | Approval |
| Cresemba | isavuconazonium sulfate | Capsule;Oral | Astellas | Labeling Revision |
| Cresemba | isavuconazonium sulfate | Injectable;Injection | Astellas | Labeling Revision |
| Finacea | azelaic acid | Gel;Topical | Bayer Hlthcare | Labeling Revision |
| Linezolid | linezolid | Tablet;Oral | Hetero Labs Ltd V | Tentative Approval |
| Moxifloxacin | moxifloxacin | Solution; Injection | Fresenius Kabi Usa | Approval |
| Nallpen In Plastic Container | nafcillin sodium | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
| Tudorza Pressair | aclidinium bromide | Powder, Metered;Inhalation | Forest Labs Inc | Labeling Revision |
April 2, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Adcirca | tadalafil | Tablet;Oral | Eli Lilly Co | Labeling Revision |
| Bidil | hydralazine hydrochloride; isosorbide dinitrate | Tablet;Oral | Arbor Pharms Llc | Labeling Revision |
| Dolophine Hydrochloride | methadone hydrochloride | Syrup;Oral | Roxane | Labeling Revision |
| Dolophine Hydrochloride | methadone hydrochloride | Tablet;Oral | Roxane | Labeling Revision |
| Temodar | temozolomide | Capsule;Oral | Merck Sharp Dohme | Labeling Revision |
| Temodar | temozolomide | Powder;Intravenous | Merck Sharp Dohme | Labeling Revision |
April 1, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Arthrotec | diclofenac sodium; misoprostol | Tablet, Delayed Release;Oral | Gd Searle Llc | Labeling Revision |
| Mirapex | pramipexole dihydrochloride | Tablet;Oral | Boehringer Ingelheim | Labeling Revision |
| Norethindrone and Ethinyl Estradiol and Ferrous Fumarate | ethinyl estradiol; norethindrone | Tablet, Chewable;Oral | Famy Care Ltd | Approval |
| Sildenafil Citrate | sildenafil citrate | Solution;Intravenous | Aurobindo Pharma Ltd | Approval |
| Tussionex Pennkinetic | chlorpheniramine polistirex; hydrocodone polistirex | Suspension, Extended Release;Oral | Ucb Inc | Labeling Revision |
| Votrient | pazopanib hydrochloride | Tablet;Oral | Glaxosmithkline | Labeling Revision |
http://www.fda.gov/Drugs/NewsEvents/ucm130961.htm