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    01 1Abacavir Sulfate

    02 1Abaloparatide

    03 1Abametapir

    04 1Abemaciclib

    05 2Acyclovir

    06 1Adefovir Dipivoxil

    07 1Adenine

    08 1Alendronate Sodium

    09 1Allopurinol

    10 1Almotriptan Malate

    11 1Alprazolam

    12 1Ambrisentan

    13 1Amiloride Hydrochloride

    14 3Amlodipine Besylate

    15 1Apalutamide

    16 1Apixaban

    17 1Apremilast

    18 2Aripiprazole

    19 1Armodafinil

    20 1Asenapine Maleate

    21 2Atazanavir Sulfate

    22 1Atenolol

    23 1Atomoxetin Hydrochloride

    24 4Atorvastatin

    25 1Atovaquone

    26 1Atropine Sulfate

    27 1Avatrombopag Maleate

    28 1Azacitidine

    29 1Azathioprine

    30 1Azelastine Hydrochloride

    31 1Azilsartan

    32 1Azithromycin

    33 1Azithromycin Dihydrate

    34 1Baclofen

    35 1Baricitinib

    36 1Bedaquiline

    37 1Betrixaban Maleate

    38 1Bexarotene

    39 1Bicalutamide

    40 1Bictegravir Sodium

    41 1Bilastine

    42 1Blonanserin

    43 1Bortezomib

    44 2Bosentan Hydrate

    45 1Brexpiprazole

    46 1Brigatinib

    47 1Bromfenac Sodium

    48 1Busulfan

    49 2Canagliflozin

    50 1Candesartan Cilexetil

    51 1Capecitabine

    52 1Carfilzomib

    53 1Carvedilol

    54 1Carvedilol Phosphate

    55 2Celecoxib

    56 1Cetirizine

    57 2Cetirizine Dihydrochloride

    58 1Cevimeline Hydrochloride

    59 1Chlorthalidone

    60 1Ciprofloxacin

    61 2Ciprofloxacin Hydrochloride

    62 1Citalopram

    63 2Citalopram Hydrobromide

    64 3Clarithromycin

    65 1Clindamycin Palmitate

    66 1Clobetasone Butyrate

    67 1Clofarabine

    68 1Clopidogrel

    69 1Clozapine

    70 2Cobicistat

    71 1Colestipol

    72 1Dacarbazine

    73 1Daclatasvir

    74 1Darifenacin Hydrobromide

    75 2Darunavir

    76 1Darunavir Ethanolate

    77 1Dasatinib

    78 3Deferasirox

    79 1Desloratadine

    80 1Desmopressin Acetate

    81 1Desvenlafaxine Succinate

    82 1Deutetrabenazine

    83 2Dexlansoprazole

    84 1Dextromethorphan

    85 1Didanosine

    86 1Diflunisal

    87 1Dimethyl Fumarate

    88 1Diphenoxylate Hydrochloride

    89 1Dipyridamole

    90 1Dofetilide

    91 2Dolutegravir Sodium

    92 1Doravirine

    93 1Doxazosin Mesylate

    94 1Dronedarone Hydrochloride

    95 1Droxidopa

    96 1Duloxetine Hydrochloride

    97 1Edoxaban Tosylate

    98 5Efavirenz

    99 1Efinaconazole

    100 2Eletriptan Hydrobromide

    101 2Elvitegravir

    102 1Empagliflozin

    103 3Emtricitabine

    104 1Enrofloxacin

    105 1Enzalutamide

    106 1Epinephrine

    107 1Epinephrine Bitartrate

    108 1Eprosartan

    109 1Eprosartan Mesylate

    110 2Erlotinib Hydrochloride

    111 1Escitalopram Oxalate

    112 3Esomeprazole Magnesium

    113 1Eszopiclone

    114 1Ethacrynic Acid

    115 1Etoricoxib

    116 1Etravirine

    117 1Exemestane

    118 1Ezetimibe

    119 1Febantel

    120 1Febuxostat

    121 2Felbamate

    122 1Ferric Carboxymaltose

    123 1Fexofenadine Hydrochloride

    124 1Fingolimod Hydrochloride

    125 1Fluconazole

    126 1Fludrocortisone Acetate

    127 1Fluocytosine

    128 1Fluticasone Propionate

    129 1Fomepizole

    130 1Fondaparinux Sodium

    131 1Formoterol Fumarate

    132 1Fosamprenavir

    133 1Frovatriptan

    134 1Frovatriptan Succinate Hydrate

    135 1Gabapentin

    136 1Garenoxacin

    137 1Gatifloxacin

    138 1Gemcitabine

    139 1Ibandronate Sodium

    140 1Ibrutinib

    141 1Icatibant Acetate

    142 1Idelalisib

    143 1Iloperidone

    144 1Imatinib Mesylate

    145 1Indinavir

    146 1Irbesartan

    147 1Iron Dextran

    148 2Iron Sucrose

    149 1Isosulfan Blue

    150 1Itraconazole

    151 1Labetalol Hydrochloride

    152 3Lamivudine

    153 1Lamotrigine

    154 1Lanreotide Acetate

    155 1Lansoprazole

    156 2Lanthanum Carbonate

    157 1Larotrectinib

    158 1Latanoprost

    159 1Ledipasvir

    160 1Lenalidomide

    161 1Letrozole

    162 1Leuprolide Acetate

    163 1Levetiracetam

    164 1Levofloxacin

    165 1Linaclotide

    166 1Linagliptin

    167 1Linezolid

    168 1Liraglutide

    169 1Lisinopril

    170 2Lopinavir

    171 2Loratadine

    172 1Losartan Potassium

    173 1Lumacaftor

    174 1Lurasidone Hydrochloride

    175 1Macitentan

    176 2Mafenide

    177 1Maraviroc

    178 1Memantine Hydrochloride

    179 1Mesalazine

    180 1Miglustat

    181 1Milnacipran Hydrochloride

    182 2Mirtazapine

    183 1Modafinil

    184 1Molindone

    185 1Montelukast Sodium

    186 1Moxifloxacin Hydrochloride

    187 1Nabumetone

    188 1Nadolol

    189 1Naproxen

    190 1Naproxen Sodium

    191 1Nelfinavir Mesylate

    192 2Nepafenac

    193 1Netupitant

    194 3Nevirapine

    195 1Nifedipine

    196 1Nintedanib Esylate

    197 1Nitrofurantoin

    198 1Octreotide Acetate

    199 1Olanzapine

    200 1Olmesartan Medoxomil

    201 1Olsalazine

    202 1Omeprazole Magnesium

    203 1Oseltamivir Phosphate

    204 1Osimertinib Mesylate

    205 1Oxybutynin Hydrochloride

    206 1Ozanimod

    207 1Palbociclib

    208 1Paliperidone

    209 2Paliperidone Palmitate

    210 2Pantoprazole Sodium

    211 1Parecoxib Sodium

    212 2Paroxetine Hydrochloride

    213 1Pemetrexed Disodium

    214 1Penciclovir

    215 1Pentosan Polysulfate Sodium

    216 1Pentostatin

    217 1Perindopril Erbumine

    218 1Phenoxybenzamine HCl

    219 1Phentolamine Mesylate

    220 1Pioglitazone Hydrochloride

    221 1Pirfenidone

    222 1Pitavastatin

    223 1Plecanatide

    224 1Plerixafor

    225 2Pomalidomide

    226 1Ponatinib

    227 1Pramipexole Dihydrochloride

    228 2Prasugrel

    229 1Prasugrel Hydrochloride

    230 3Pregabalin

    231 1Pretomanid

    232 1Primaquine Diphosphate

    233 1Procarbazine Hydrochloride

    234 1Proguanil

    235 1Propafenone Hydrochloride

    236 1Pyrazinamide

    237 1Pyronaridine Tetraphosphate

    238 1Quetiapine Hemifumarate

    239 1Quinapril

    240 1Rabeprazole Sodium

    241 2Raltegravir Potassium

    242 1Rasagiline Mesylate

    243 1Regadenoson Monohydrate

    244 1Regorafenib

    245 1Ribociclib

    246 1Rilpivirine Hydrochloride

    247 1Risedronate Sodium

    248 2Risperidone

    249 2Ritonavir

    250 1Rivaroxaban

    251 2Rivastigmine

    252 1Rivastigmine Tartrate

    253 1Rizatriptan Benzoate

    254 1Roflumilast

    255 1Romidepsin

    256 1Rosiglitazone

    257 1Rosuvastatin Calcium

    258 1Rotigotine

    259 1Roxadustat

    260 1Rucaparib Camsylate

    261 2Sacubitril Sodium

    262 1Sacubitril-Valsartan

    263 1Safinamide Methanesulfonate

    264 1Salmeterol Xinafoate

    265 1Saxagliptin

    266 1Saxagliptin Hydrochloride

    267 1Selegiline Hydrochloride

    268 1Selexipag

    269 1Semaglutide

    270 2Sertraline Hydrochloride

    271 1Sevelamer Carbonate

    272 1Sevelamer Hydrochloride

    273 1Sibutramine Hydrochloride

    274 2Sildenafil Citrate

    275 1Simvastatin

    276 1Sincalide

    277 1Sitagliptin Hydrochloride

    278 1Sitagliptin Phosphate

    279 1Sodium Nitroprusside

    280 1Sodium ferric gluconate

    281 1Sofosbuvir

    282 1Sotagliflozin

    283 3Stavudine

    284 1Sugammadex Sodium

    285 1Sulfiram

    286 1Sumatriptan

    287 1Sunitinib

    288 1Suvorexant

    289 2Tadalafil

    290 1Telbivudine

    291 1Telmisartan

    292 1Temazepam

    293 2Tenofovir Alafenamide Fumarate

    294 2Tenofovir Disoproxil Fumarate

    295 1Terbinafine Hydrochloride

    296 2Tetrabenazine

    297 1Thalidomide

    298 1Thiotepa

    299 1Tiaprofenic Acid

    300 1Ticagrelor

    301 1Tizanidine Hydrochloride

    302 1Tofacitinib Citrate

    303 1Tolmetin Sodium

    304 2Tolterodine Tartrate

    305 1Trametinib

    306 1Trazodone Hydrochloride

    307 1Treprostinil Diolamine

    308 1Trientine Hydrochloride

    309 1Trifluridine

    310 1Upadacitinib

    311 1Vadadustat

    312 3Valacyclovir Hydrochloride

    313 1Valbenazine Tosylate

    314 2Valganciclovir Hydrochloride

    315 1Valsartan

    316 1Vardenafil Hydrochloride

    317 1Varenicline Tartrate

    318 1Velpatasvir

    319 1Venetoclax

    320 1Venlafaxine Hydrochloride

    321 1Verapamil Hydrochloride

    322 1Vilazodone Hydrochloride

    323 1Vildagliptin

    324 1Vonoprazan Fumarate

    325 1Voriconazole

    326 1Vorinostat

    327 1Vortioxetine Hydrobromide

    328 3Zidovudine

    329 1Zileuton

    330 1Zofenopril Calcium

    331 1Zoledronic Acid

    332 1Zolmitriptan

    333 1Zolpidem Tartrate

    334 1Zonisamide

    335 4Blank

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    01

    Lanthanum Carbonate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Antibody Engineering
    Not Confirmed
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    Lanthanum Carbonate

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Antibody Engineering
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21958

    Submission : 2008-09-05

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 228MF10230

    Registrant's Address : Plot No. 14, 99 and 100, IDA, Pashamylaram Phase-II, Patancheru, Sangareddy District - 502307, Telangana, India

    Initial Date of Registration : 2016-12-14

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2023-05-10

    Valid Till : 2026-05-10

    Written Confirmation Number : WC-0015

    Address of the Firm :

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    02

    Sildenafil Citrate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Antibody Engineering
    Not Confirmed
    arrow

    Sildenafil Citrate

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Antibody Engineering
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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2025-10-20

    Pay. Date : 2025-10-14

    DMF Number : 19097

    Submission : 2006-01-10

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 224MF10197

    Registrant's Address : Plot No. 14, 99 and 100, IDA, Pashamylaram Phase-II, Patancheru, Sangareddy District - 502307, Telangana, India

    Initial Date of Registration : 2012-09-11

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2023-05-10

    Valid Till : 2026-05-10

    Written Confirmation Number : WC-0015

    Address of the Firm :

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    NDC Package Code : 65015-861

    Start Marketing Date : 2018-07-11

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
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    Registrant Name : Pharmapia Co., Ltd.

    Registration Date : 2020-10-08

    Registration Number : 20200602-209-J-644(1)

    Manufacturer Name : Tianish Laboratories Private Limited (Unit-9)

    Manufacturer Address : Plot No. 5, Road No. 12, Tadi(V) JNPharma City, Parawada(M), Visakhapatnam District Andrea Pradesh, India

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    03

    Valsartan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Antibody Engineering
    Not Confirmed
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    Valsartan

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Antibody Engineering
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-07-11

    Pay. Date : 2013-06-26

    DMF Number : 18253

    Submission : 2005-04-07

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
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    Registration Number : 226MF10153

    Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India

    Initial Date of Registration : 2014-09-01

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2023-05-10

    Valid Till : 2026-05-10

    Written Confirmation Number : WC-0015

    Address of the Firm :

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    04

    Ritonavir

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Antibody Engineering
    Not Confirmed
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    Ritonavir

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Antibody Engineering
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-11-08

    Pay. Date : 2012-10-30

    DMF Number : 19800

    Submission : 2006-09-26

    Status : Active

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R0-CEP 2014-209 - Rev 00

    Issue Date : 2015-11-12

    Type : Chemical

    Substance Number : 2136

    Status : Withdrawn by Holder

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2023-05-10

    Valid Till : 2026-05-10

    Written Confirmation Number : WC-0015

    Address of the Firm :

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    05

    Abacavir Sulfate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Antibody Engineering
    Not Confirmed
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    Abacavir Sulfate

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Antibody Engineering
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-06-16

    Pay. Date : 2017-05-11

    DMF Number : 18229

    Submission : 2005-03-30

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2023-05-10

    Valid Till : 2026-05-10

    Written Confirmation Number : WC-0015

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 65015-640

    Start Marketing Date : 2015-02-13

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    06

    Acyclovir

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Antibody Engineering
    Not Confirmed
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    Acyclovir

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Antibody Engineering
    Not Confirmed
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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-12-26

    Pay. Date : 2012-11-19

    DMF Number : 13277

    Submission : 1998-10-22

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 218MF10974

    Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India

    Initial Date of Registration : 2006-12-01

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Bukwang Pharmaceutical Co., Ltd.

    Registration Date : 2018-05-04

    Registration Number : 20050831-33-A-83-09(3)

    Manufacturer Name : Mylan Laboratories Limited

    Manufacturer Address : 14, 99 & 100, Industrial Development Area Pashamylaram, Phase-II, Patancheru, 502 307, Medak District, Telangana, India

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    07

    Alendronate Sodium

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Antibody Engineering
    Not Confirmed
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    Alendronate Sodium

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Antibody Engineering
    Not Confirmed
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    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20402

    Submission : 2007-04-02

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 220MF10178

    Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India

    Initial Date of Registration : 2008-07-31

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 65015-683

    Start Marketing Date : 2015-02-13

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    08

    Allopurinol

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Antibody Engineering
    Not Confirmed
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    Allopurinol

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Antibody Engineering
    Not Confirmed
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16409

    Submission : 2003-04-23

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
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    Registration Number : 217MF10578

    Registrant's Address : Plot No. 14, 99 and 100, IDA, Pashamylaram Phase-II, Patancheru, Sangareddy District - 502307, Telangana, India

    Initial Date of Registration : 2005-09-14

    Latest Date of Registration :

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    NDC Package Code : 65015-606

    Start Marketing Date : 2015-02-12

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-10-20

    Pay. Date : 2014-04-15

    DMF Number : 24505

    Submission : 2010-12-21

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
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    Date of Issue : 2023-05-10

    Valid Till : 2026-05-10

    Written Confirmation Number : WC-0015

    Address of the Firm :

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    NDC Package Code : 65015-793

    Start Marketing Date : 2015-02-12

    End Marketing Date : 2025-12-31

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    DMF Review : N/A

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    DMF Number : 20419

    Submission : 2007-03-27

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
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    Date of Issue : 2023-05-10

    Valid Till : 2026-05-10

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    NDC Package Code : 65015-678

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