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    01 1ATRACURIUM BESYLATE

    02 1AZACITIDINE

    03 1AZITHROMYCIN DIHYDRATE

    04 2AZITHROMYCIN MONOHYDRATE

    05 1AZITHROMYCIN N

    06 1AZTREONAM

    07 1AZTREONAM USP

    08 1BECLOMETHASONE DIPROPIONATE

    09 1BECLOMETHASONE DIPROPIONATE ANHYDROUS, BULK DRUG SUBSTANCE

    10 1BECLOMETHASONE DIPROPIONATE MONOHYDRATE

    11 1BETAMETHASONE ACETATE

    12 1BETAMETHASONE DIPROPIONATE

    13 1BETAMETHASONE VALERATE

    14 1BICALUTAMIDE

    15 1BIVALIRUDIN

    16 1BLEOMYCIN SULFATE

    17 1BORTEZOMIB

    18 1BREXPIPRAZOLE

    19 1BROMOCRIPTINE MESYLATE

    20 2BUDESONIDE

    21 1BUPRENORPHINE

    22 1BUPRENORPHINE HYDROCHLORIDE

    23 1BUTORPHANOL TARTRATE

    24 1CABAZITAXEL

    25 1CABERGOLINE

    26 1CALCIPOTRIENE USP

    27 1CALCITRIOL USP

    28 1CANDESARTAN CILEXETIL

    29 1CAPECITABINE

    30 2CARBAMAZEPINE USP

    31 1CARBIDOPA

    32 1CARBIDOPA USP (DRUG SUBSTANCE)

    33 1CARBOPLATIN

    34 1CARFILZOMIB

    35 1CARVEDILOL PHOSPHATE

    36 1CARVEDILOL USP

    37 1CASPOFUNGIN

    38 1CASPOFUNGIN ACETATE

    39 1CEFACLOR USP

    40 1CEFADROXIL

    41 1CEFAZOLIN SODIUM

    42 1CEFDINIR HYDRATE

    43 1CEFPROZIL

    44 1CEPHALEXIN

    45 1CEPHALOSPORIN G

    46 1CEPHRADINE

    47 1CHLORTHALIDONE

    48 1CILOSTAZOL USP

    49 1CINACALCET HYDROCHLORIDE

    50 1CISATRACURIUM BESYLATE

    51 1CLARITHROMYCIN USP

    52 2CLOBETASOL PROPIONATE

    53 1CLOMIPHENE CITRATE

    54 1CLOPIDOGREL BISULFATE USP

    55 1CLOXACILLIN SODIUM

    56 1CO-POLYMER-1 (COP-1)

    57 1CRISABOROLE

    58 1CYCLACILLIN

    59 2CYCLOSPORINE

    60 1CYCLOSPORINE ID: 741310

    61 1CYCLOSPORINE ID: 741710

    62 1DABIGATRAN ETEXILATE MESYLATE

    63 1DARIFENACIN HYDROBROMIDE

    64 1DASATINIB ANHYDROUS

    65 1DASATINIB MONOHYDRATE

    66 1DAUNORUBICIN HYDROCHLORIDE

    67 1DEFERASIROX

    68 1DEFEROXAMINE MESYLATE

    69 1DESFESOTERODINE SUCCINATE

    70 1DESLORATADINE DRUG SUBSTANCE

    71 1DESMOPRESSIN ACETATE USP

    72 1DESONIDE

    73 1DESVENLAFAXINE BASE

    74 1DESVENLAFAXINE FUMARATE

    75 1DESVENLAFAXINE SUCCINATE

    76 1DESVENLAFAXINE SUCCINATE HPMC PRELIMINARY MIX

    77 1DEXRAZOXANE (ICRF-187)

    78 1DICLOXACILLIN SODIUM

    79 1DIFLORASONE DIACETATE BULK DRUG

    80 1DIFLUPREDNATE

    81 1DIHYDRO DANE SALT

    82 1DIHYDROERGOTAMINE MESYLATE

    83 1DILTIAZEM HYDROCHLORIDE USP

    84 2DIMETHYL FUMARATE

    85 1DIROXIMEL FUMARATE

    86 1DOCETAXEL

    87 1DONEPEZIL HYDROCHLORIDE

    88 1DORZOLAMIDE HCL

    89 1DOXEPIN HCL USP

    90 1DOXERCALCIFEROL

    91 1DOXORUBICIN HYDROCHLORIDE

    92 1DROSPIRENONE

    93 1DULOXETINE HCL DRUG SUBSTANCE

    94 1ELETRIPTAN HYDROBROMIDE

    95 1EMPAGLIFLOZIN

    96 1EPIRUBICIN HYDROCHLORIDE LYOPHILIZED

    97 1EPIRUBICIN HYDROCHLORIDE PRECIPITATED

    98 1EPTIFIBATIDE

    99 1ERGOLOID MESYLATES

    100 1ERGONOVINE MALEATE

    101 1ERGOTAMINE TARTRATE

    102 1ERLOTINIB HCL

    103 1ESTROGENIC LIQUIDS

    104 1ESTROGENIC POWDERS

    105 1ESZOPICLONE ( PROCESS I )

    106 1ESZOPICLONE (PROCESS II)

    107 1ETODOLAC

    108 1ETOPOSIDE

    109 1EXENATIDE

    110 1EZETIMIBE

    111 1EZETIMIBE DRUG SUBSTANCE

    112 1FAMCICLOVIR

    113 1FEBUXOSTAT

    114 1FENOFIBRATE CHOLINE

    115 1FEXOFENADINE BASE

    116 1FEXOFENADINE HYDROCHLORIDE

    117 1FINGOLIMOD HYDROCHLORIDE

    118 1FLUDARABINE PHOSPHATE

    119 1FLUDROCORTISONE ACETATE

    120 1FLUNISOLIDE ANHYDROUS

    121 1FLUNISOLIDE ANHYDROUS (NEW PROCESS)

    122 1FLUOCINOLONE ACETONIDE (PROCESS I)

    123 1FLUOCINOLONE ACETONIDE - PROCESS II

    124 1FLUOCINONIDE

    125 1FLUOCINONIDE (NEW PROCESS)

    126 1FLUOROMETHOLONE-17-ACETATE

    127 1FLUOXETINE HCI

    128 1FLUTICASONE PROPIONATE

    129 1FLUVASTATIN SODIUM

    130 1FLUVOXAMINE MALEATE

    131 1FORMOTEROL FUMARATE DIHYDRATE

    132 1FOSAMPRENAVIR CALCIUM

    133 2FULVESTRANT

    134 1FUROSEMIDE USP

    135 1GABAPENTIN

    136 1GABAPENTIN BUTANOL PROCESS

    137 1GALANTHAMINE HYDROBROMIDE

    138 1GATIFLOXACIN

    139 1GEMCITABINE HYDROCHLORIDE

    140 1GEMCITABINE HYDROCHLORIDE (A-MESYLRIBOSE PROCESS)

    141 1GEMFIBROZIL USP

    142 1HALOBETASOL PROPIONATE

    143 1HALOPERIDOL

    144 1HALOPERIDOL DECANOATE

    145 2HYDROCHLOROTHIAZIDE

    146 1HYDROCORTISONE BUTYRATE DRUG SUBSTANCE

    147 1IBANDRONATE SODIUM

    148 1IBRUTINIB

    149 1ICATIBANT ACETATE

    150 1IDARUBICIN HYDROCHLORIDE

    151 1IMATINIB MESYLATE

    152 1IMATINIB MESYLATE FORM ALPHA

    153 1IMIPRAMINE HYDROCHLORIDE USP

    154 1IMIQUIMOD

    155 1IRBESARTAN

    156 1IRBESARTAN USP

    157 2LABETALOL HYDROCHLORIDE

    158 1LACOSAMIDE

    159 1LAMOTRIGINE

    160 1LANSOPRAZOLE

    161 1LATANOPROST

    162 1LETROZOLE

    163 1LEUPROLIDE ACETATE

    164 1LEVALBUTEROL HYDROCHLORIDE

    165 1LEVETIRACETAM

    166 1LEVODOPA

    167 1LEVOFLOXACIN

    168 1LINACLOTIDE

    169 1LINAGLIPTIN

    170 1LINEZOLID

    171 1LISINOPRIL DRUG SUBSTANCE

    172 1LISURIDE

    173 1LISURIDE HYDROGENMALEATE

    174 1LOPERAMIDE HYDROCHLORIDE

    175 1LORAZEPAM

    176 2LOSARTAN POTASSIUM

    177 1LOVASTATIN USP

    178 1LR-103

    179 1LUBIPROSTONE

    180 1LURASIDONE HYDROCHLORIDE

    181 1MACITENTAN

    182 1MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN BEER SHEVA, ISREAL.

    183 1MEDROXYPROGESTERONE ACETATE

    184 1MEGESTROL ACETATE

    185 1MEMANTINE HYDROCHLORIDE

    186 1MESALAZINE N

    187 1METFORMIN HYDROCHLORIDE DRUG SUBSTANCE

    188 1METHYLDOPA

    189 1METHYLERGONOVINE MALEATE USP

    190 1METOPROLOL SUCCINATE

    191 1METOPROLOL TARTRATE

    192 1METOPROLOL TARTRATE USP

    193 1MICAFUNGIN SODIUM

    194 1MIRTAZAPINE

    195 1MISOPROSTOL

    196 1MISOPROSTOL HPMC DISPERSION 1:100

    197 1MITOMYCIN

    198 1MITOXANTRONE HYDROCHLORIDE USP

    199 1MODAFINIL

    200 1MOMETASONE FUROATE USP

    201 2MONTELUKAST SODIUM

    202 2MUPIROCIN

    203 1MUPIROCIN CALCIUM

    204 1MUPIROCIN CALCIUM DIHYDRATE

    205 1MYCOPHENOLATE MOFETIL DRUG SUBSTANCE

    206 1MYCOPHENOLATE SODIUM

    207 1NAPROXEN

    208 1NAPROXEN AND NAPROXEN SODIUM USP

    209 1NATEGLINIDE

    210 1NEFAZODONE HYDROCHLORIDE USP

    211 1NIFEDIPINE

    212 1NILOTINIB HYDROCHLORIDE

    213 1NILOTINIB HYDROCHLORIDE FORM ALPHA

    214 1NITISINONE

    215 1NORGESTIMATE BULK DRUG SUBSTANCE

    216 1OCTREOTIDE ACETATE

    217 1OLANZAPINE USP

    218 1OLMESARTAN MEDOXOMIL USP

    219 1OMEPRAZOLE

    220 1ONDANSETRON BASE

    221 1ONDANSETRON HCL DIHYDRATE

    222 1ONDANSETRON HYDROCHLORIDE DIHYDRATE

    223 1OXACILLIN SODIUM

    224 1OXALIPLATIN

    225 1OXAZEPAM

    226 1PACLITAXEL

    227 1PACLITAXEL SEMISYNTHETIC

    228 1PACLITAXEL SEMISYNTHETIC (9-DHB)

    229 1PACLITAXEL SEMISYNTHETIC (FROM 10-DAB)

    230 1PALBOCICLIB

    231 1PALIPERIDONE

    232 1PALONOSETRON HCL

    233 1PALONOSETRON HYDROCHLORIDE

    234 1PAMIDRONATE BULK CHEMICAL

    235 1PANCURONIUM BROMIDE

    236 2PANTOPRAZOLE SODIUM

    237 1PARAHYDROXY DANE SALT

    238 1PARICALCITOL USP

    239 1PAROXETINE HYDROCHLORIDE HEMIHYDRATE

    240 1PEMETREXED DIACID

    241 1PENICILLIN G SULFOXIDE

    242 1PENICILLIN V POTASSIUM

    243 1PENTOXIFYLLINE USP

    244 1PERAMPANEL

    245 1PERGOLIDE MESYLATE

    246 1PIOGLITAZONE HYDROCHLORIDE

    247 1POTASSIUM CITRATE USP

    248 1PRALATREXATE

    249 1PRASUGREL HYDROCHLORIDE

    250 1PRAVASTATIN SODIUM

    251 1PREDNICARBATE DRUG SUBSTANCE

    252 1PREGABALIN D9333

    253 1PREGABALIN DRUG SUBSTANCE

    254 1PROBENECID USP

    255 1QUETIAPINE FUMARATE DRUG SUBSTANCE

    256 1RALOXIFENE HYDROCHLORIDE

    257 1RALOXIFENE HYDROCHLORIDE BULK DRUG SUBSTANCE

    258 1RAMELTEON

    259 1RASAGILINE MESYLATE

    260 1RISEDRONATE SODIUM

    261 1RISPERIDONE USP

    262 1RIVAROXABAN

    263 1ROCURONIUM BROMIDE

    264 1ROMIDEPSIN

    265 1ROSIGLITAZONE MALEATE

    266 1ROSUVASTATIN CALCIUM (BULK)

    267 1ROSUVASTATIN CALCIUM PROCESS G

    268 1ROSUVASTATIN CALCIUM PROCESS G 2410

    269 1ROTIGOTINE

    270 1SACUBITRIL/VALSARTAN

    271 1SAXAGLIPTIN MONOHYDRATE

    272 1SD-809 DEUTETRABENAZINE

    273 1SELEGILINE HYDROCHLORIDE

    274 1SERTRALINE HYDROCHLORIDE

    275 1SILDENAFIL CITRATE

    276 1SILVER SULFADIAZINE

    277 1SIMVASTATIN

    278 1SIMVASTATIN (ETHANOL PROCESS)

    279 2SITAGLIPTIN PHOSPHATE

    280 1SITAGLIPTIN PHOSPHATE ENZYMATIC

    281 1SODIUM ALENDRONATE

    282 1SOFOSBUVIR 1213

    283 1SOFOSBUVIR 1613

    284 1SOLIFENACIN SUCCINATE

    285 1SORAFENIB TOSYLATE

    286 1SUGAMMADEX SODIUM

    287 1SULFAMETHOXAZOLE

    288 1SULFAMETHOXAZOLE USP

    289 1SUNITINIB MALATE

    290 1SYNTHETIC CONJUGATED ESTROGENS, A(F00375)

    291 1TACROLIMUS

    292 1TADALAFIL

    293 1TAMOXIFEN CITRATE USP

    294 1TELMISARTAN

    295 1TERAZOSIN HCI 2H20

    296 1TERAZOSIN HCI DIHYDRATE

    297 1TERAZOSIN HYDROCHLORIDE

    298 1TERBINAFINE HYDROCHLORIDE

    299 1TERFENADINE

    300 1TERGURIDE HYDROGENMALEATE

    301 1TERIPARATIDE ACETATE

    302 1THIOTEPA

    303 1TICAGRELOR

    304 1TICLOPIDINE HCL

    305 1TIGECYCLINE

    306 1TIMOLOL MALEATE

    307 1TIOTROPIUM BROMIDE

    308 1TOBRAMYCIN

    309 1TOLTERODINE TARTRATE

    310 2TORSEMIDE

    311 1TRAZODONE HYDROCHLORIDE

    312 1TRAZODONE HYDROCHLORIDE USP

    313 1TRIAMCINOLONE ACETONIDE

    314 1TRIAMCINOLONE ACETONIDE MICRONIZED STERILE

    315 1TRIMETHOPRIM USP

    316 1TRIMIPRAMINE MALEATE

    317 1ULIPRISTAL ACETATE

    318 1UMECLIDINIUM BROMIDE

    319 1VALACYCLOVIR HYDROCHLORIDE

    320 1VALRUBICIN (AD-32)

    321 1VECURONIUM BROMIDE

    322 2VENLAFAXINE HYDROCHLORIDE

    323 1VERAPAMIL HYDROCHLORIDE

    324 1VILAZODONE HYDROCHLORIDE

    325 1WARFARIN SODIUM CLATHRATE

    326 1ZALEPLON

    327 1ZOLEDRONATE DISODIUM

    328 1ZOLEDRONIC ACID

    329 1ZOLMITRIPTAN

    330 2ZOLPIDEM TARTRATE

    331 1ZONISAMIDE

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    01

    Atracurium Besylate

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    DMF Review : Complete

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    Azacitidine

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    DMF Review : Complete

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    Azithromycin Dihydrate

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    Azithromycin Monohydrate

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    Azithromycin Monohydrate

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    Azithromycin N

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    DMF Review : Complete

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    Aztreonam

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    Submission : 2003-08-08

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    08

    Aztreonam Usp

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    DMF Review : Complete

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    Beclomethasone Dipropionate

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    Beclomethasone Dipropionate Anhydrou...

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