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Company N 022206 RAPAFLO SILODOSIN WATSON LABS / NEVIRAP MATRIX LABS LTD / KEPPRA EXTENDED RELEASE TABLETS LEVETIRACETAM UCB INC / BAYER / SOLVAY / ALLERGAN / CEPHALON / AMGEN / S N 022157 XYZAL LEVOCETIRZINE DIHYDROCHLORIDE UCB INC. / S N 022023 EMEND FOSAPREPITANT DIMEGLUMINE MERCK & CO / GENZYME / GLAXOSMITHKLINE / BUPROPION HYDROBROMIDE BIOVAIL LABS / EISAI / DOCETAXEL INJECTION DOCETAXEL INJECTION HOSPIRA INC / VIMPAT INJECTION LACOSAMIDE DURAMED SCHWARZ BIOSCIENCES SCHWARZ BIOSCIENCES / TEVA / GE HEALTHCARE / CLEVIPREX CLEVIDIPINE BUTYRATE BANNER MEDICINES COMPANY / FLUOR / CLINDAMYCIN PHOSPHATE ALUCEN TEVA PARENTERAL 5 DOW PHARMACEUTICAL / L'OREAL / WYETH / ASTRAZENECA / STAVUDINE CIPLA LIMITED / NOVO NORDISK / TENOFAVIR DISOPROXYL FURMATE/LAMIVUDINE FURMATE/LAMIVUDINE MATRIX LABS / / Event FDA Phase / / Person LEO PHARM / / Position President / / Product CLINDAMYCIN PHOSPHATE / PHENTOLAMINE MESYLATE / LEUCOVORIN CALCIUM / ESOMEPRAZOLE MAGNESIUM / MORPHINE SULFATE / FLUVOXAMINE MALEATE / ABACAVIR SULFATE / DOCETAXEL INJECTION DOCETAXEL INJECTION / PREDNISOLONE ACETATE / NICARDIPINE HYDROCHLORIDE / ZOLPIDEM TARTRATE / TRAMADOL HYDROCHLORIDE / FLO-PRED / VENLAFAXINE HYDROCHLORIDE / LAMIVUDINE; STAVUDINE / PANTOPRAZOLE SODIUM / STAVUDINE; LAMIVUDINE; NEVIRAPINE / LUVOX CR / RUFINAMIDE TABLETS / AMIODARONE HYDROCHLORIDE / N022167 lamivudine 30mg/stavudine 6mg Tablets / NOVOLOG MIX / DOCETAXEL INJECTION / CEFEPIME INJECTION CEFEPIME INJECTION / TEKTURNA HCT / EOVIST INJECTION / VALPROIC ACID / OLOPATADINE HYDROCHLORIDE / VIMPAT TABLETS / VIMPAT INJECTION / LIDOCAINE HYDROCHLORIDE / TRIAMCINOLONE ACETONIDE / FLUDARABINE PHOSPHATE / BETAMETHASONE DIPROPIONATE / METFORMIN HYDROCHLORIDE / FLUORESCEIN INJECTION / DESMOPRESSIN ACETATE / NAPROXEN SODIUM / N022167 / Mar-08 / N022141 / N022177 / Dec-08 / N022293 / / PublishedMedium Public Law / /
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CDER Drug and Biologic Approvals for Calendar Year 2008 Updated through December 31, 2008 New Drug Application (NDA) Approvals: Application Type