US DMF (total 50)

SubstanceDMF number
AbemaciclibDMF # 041250; date of submission: Jan. 24, 2025
Anastrozole

DMF # 020282; date of submission: Feb. 15, 2007

Avobenzone

DMF # 017755; date of submission: Oct. 12, 2004

Balsalazide

DMF # 017326; date of submission: Apr. 19, 2004

Benzonatate

DMF # 021703; date of submission: Jun. 16, 2008

Calcifediol

DMF # 033640; date of submission: May. 03, 2019

Calcipotriol

DMF # 019415; date of submission: Mar. 31, 2006

Calcipotriol Monohydrate

DMF # 023267; date of submission: Nov. 13, 2009

Calcitriol

DMF # 018227; date of submission: Mar. 21, 2005

Calcium Acetate

DMF # 023735; date of submission: Apr. 21, 2010

Capsaicin

DMF # 016769; date of submission: Aug. 18, 2003

Colesevelam HCl

DMF # 022870; date of submission: Jun. 16, 2009
DMF # 030001; date of submission: Nov. 13, 2015

Colestipol HCl

DMF # 017651; date of submission: Sep. 02, 2004

DDAIP

DMF # 019586; date of submission: May 18, 2006

Dinalbuphine Sebacate

DMF # 032476; date of submission: Mar. 22, 2018

Doxercalciferol

DMF # 022136; date of submission: Oct. 31, 2008

Elagolix Sodium

DMF # 034907; date of submission: Jun. 30, 2020

Ergocalciferol

DMF # 024189; date of submission: Sep. 20, 2010

Eribulin Mesylate

DMF # 035358; date of submission: Nov. 30, 2020

Ferric Carboxymaltose

DMF # 035442; date of submission: Dec. 31, 2020

Fondaparinux Sodium

DMF # 027475; date of submission: Sep. 17, 2013

Gadobutrol Monohydrate

DMF # 036660; date of submission: Dec. 30, 2021

Gadoterate Meglumine

DMF # 034129; date of submission: Sep. 12, 2019

Iloperidone

DMF # 024481; date of submission: Dec. 22, 2010

Imatinib Mesylate

DMF # 035153; date of submission: Oct. 20, 2020

Ixabepilone

DMF # 025894; date of submission: Apr. 03, 2012

Lapatinib Ditosylate

DMF # 024788; date of submission: Mar. 18, 2011

Leflunomide

DMF # 016038; date of submission: Jun. 27, 2002

Levonorgestrel

DMF # 021634; date of submission: May 20, 2008

Linezolid

DMF # 025700; date of submission: Jan. 09, 2012

Mifepristone

DMF #027474; date of submission: Sep. 13, 2013

Mycophenolate Sodium

DMF # 024397, date of submission: Nov. 19, 2010

Mycophenolate Mofetil

DMF # 022046; date of submission: Oct. 02, 2008

Meprobamate

DMF # 020465; date of submission: Apr. 23, 2007

Montelukast

DMF # 021702; date of submission: Jun. 16, 2008

Mycophenolic Acid

DMF # 021952; date of submission: Sep. 05, 2008

Nintedanib

DMF # 032408; date of submission: Jan. 05, 2018

Nintedanib Esylate

DMF # 032643; date of submission: Apr. 02, 2018

Orlistat

DMF # 023978; date of submission: Jul. 19, 2010

Paricalcitol

DMF # 021880; date of submission: Aug. 14, 2008

Patiromer Sorbitex Calcium

DMF # 032966; date of submission: Jun. 06, 2019

Pazopanib Hydrochloride

DMF # 031297; date of submission: Jan. 03, 2017

Rucaparib Camsylate

DMF # 034419; date of submission: Dec. 26, 2019

Sevelamer Carbonate

DMF # 23039; date of submission: Aug. 13, 2009
DMF # 030002; date of submission: Nov. 13, 2015

Sevelamer HCl

DMF # 22631; date of submission: Mar. 16, 2009

Temozolomide

DMF # 23158; date of submission: Oct. 06, 2009

Teriflunomide

DMF # 029862; date of submission: Dec. 31, 2015

Ulipristal Acetate

DMF # 25701; date of submission: Jan. 09, 2012


 

CEP (total 8)

SubstanceCEP number
Calcifediol MonohydrateCEP2019-163
Calcipotriol AnhydrousCEP2007-243
Calcipotriol MonohydrateCEP2010-187
CalcitriolCEP2009-377
CEP2020-150
LeflunomideCEP2009-035
Montelukast SodiumCEP2013-278
TemozolomideCEP2017-245

 

EU DMF (total 20)

SubstanceDMF number
AlfacalcidolItaly: # 8906.132.35.405
Greece: # 791
AnastrozoleCZ: sukls153335/2015
DE: 1612
DK: 2215-1208
ES: AW/1936/07
NL: 1533
PL: PL/DC/4003-04444-2006
SE: Dnr 116:2007/17567 
UK: MFD-31818-1-02509
CalcitriolGR: 792
IT: 8906.130.67.799
CapsaicinGreece: # 1714
DE: #3723
ES: AA/01334/18
Colesevelam HydrochlorideUK: # MFD-31818-2-07236
DE: #4427
Eribulin MesylateDE: 4990
GR(EOF): 145483/27-12-2023
AT: 552899
CY: 2023-DMF-1946
CZ: sukls308631/2023
ES: AA/0002/24
FR: 2023-134
IE: 22500009
SE: 2024/003
HR: HALMED-MF-13004 and 530-09/23-12/74
LT: 2023/1007/LT
Gadoterate MeglumineDE: #4616
GR: #3768
LinezolidAT: #551157
CZ: sukls20988/2015
DE: #3266
DK: #2215-2184
ES: AA/0128/13 and AA/0111/14
FR: #2013-081 and #2014-038
HR: # 530-09/13-12/83
IT: AIN/2014/20 and AIN/2017/1445
NL: #02793
PL: UR.DOL.OLC.4003.0302.2014 and UR.DOL.OLC.4003.0028.2015
UK: MFD-31818-1-00575
MifepristoneASMF No.: EU/ASMF/00778
Montelukast SodiumAT: #551116
CZ: # sukls10917/2014
HR: #530-09/13-12/90
NL: #021165
UK: # MFD-31818-2-07158
Mycophenolate MofetilDE: #4599
UK: MFD-31818-2-07706
MT: To be assigned
Nintedanib EsylateDE: #4839
NL: #04351
GR: 3942
CY: To be assigned
HU: To be assigned
OrlistatAT: ASMF12112
CZ: sukls103875/2013
DK: #2215-2045/201206-0834
ES: OW/3266/12
HR: #530-09/13-12/12
NL: #02581
NO: 12/5913
PL: UR.DOL.OLC.4003.0125.2012
SE: 2012/103
UK: MFD-31818-1-02752
Paricalcitol

AT: #550388
CZ: sukls210751/2013
DE: #3137
DK: #2215-1772
ES: PW/2816/10
GR: #2451
HU: OGYI/33693-2/2010
IT: AIN/2014/19
NL: #02744
PL: UR.DOL.OLC.4003.0284.2015
HR: HALMED-MF-11869 (530-09/18-12/37)

Pazopanib Hydrochloride

CZ: sukls314155/2020
DE: #4526
ES: #AA/0167/20
GR: #3690
IT: AIN/2021/2431
LV: LV/H/DMF/20/0046
LT: 2020/0701/LT
HR: 530-09/20-12/73
SE: 2020/139
PT: 134/2020
NL: 04024
FR: 2020-109
UK: MFD-31818-2-09969
HU: OGYÉI/73277/2020
SI: 1410-58/2020
DK: 2215-3130

Propiverine HydrochlorideCZ: sukls90443/2008
DE: 5690
UK: MFD-31818-2-05759
DK: 2215-1430
Sevelamer Carbonate

AT: #550953
BE: #154182
CZ: sukls213208/2018
DE: #3095 and 4646
DK: #2215-1765 and 2215-3155
ES: CS/3324/12 and AA/0125/21
FR: #2021-068 and 2012-091
GR: 91008/30-09-2021
HU: OGY/33444-1/2010
HR: #530-09/13-12/67
IT: AIN/2016/612 and AIN/2021/2471
NL: #02651 and 04154
PL: UR.DOL.OLC.4003.0224.2017
SE: #2012/090
UK: MFD-31818-2-14239

Temozolomide

DE: #3312
IT: AIN/2014/21
NL: #02854
CZ: sukls372363/2017
DK: #2215-2789
HU: OGYEI/69716-1/2017
HR: HALMED-MF-11773(530-09/17-12/63)

Teriflunomide

AT: 552542
BE: 309834
CY: 2021-DMF-1787
CZ: sukls241852/2021
DE: #4619
DK: #2215-3145
ES: AA/0093/21
FR: 2021-055
GR: 78582/26-08-2021
HR: 530-09/21-12/47
IE: 22500006
IT: AIN/2021/1855
LT: 2021/0778/LT
LV: LV/H/DMF/21/0029
NL: #04134
SI: 1410-43/2021
UK: MFD-31818-1-11101

Nonivamide

DE: #4166
LV: LV/H/DMF/20/0042
LT: 2020/0695/LT
AT: 921727 (National)
AT: 552899 (DCP)
EE: To be assigned

Japan DMF (total 14)

SubstanceDMF number
Alfacalcidol302MF10045
Gadodiamide220MF10205
Tegaful224MF10136
Gimeracil224MF10135
Oteracil Potassium224MF10134
Taltirelin hydrate224MF10029
303MF10035
Linezolid

225MF10170
226MF10166(oral)
302MF10099

Maxacalcitol226MF10138
Temozolomide228MF10143
Levonorgestrel228MF10159
Calcitriol228MF10187

 

Canada DMF (total 11)

SubstanceDMF number
Calcitriol2001-124
Capsaicin2016-181
Colesevelam Hydrochloride2021-054
Leflunomide2003-135
Linezolid2013-118
Mifepristone2024-067
Pazopanib Hydrochloride2021-104
Sevelamer Carbonate2017-009
2021-122
Sevelamer Hydrochloride2021-083
Teriflunomide2018-236

 

Australia DMF (total 8)

SubstanceDMF number
Calcipotriol monohydrateTo be assigned
Linezolid

DMF# 2014/001920

Montelukast Sodium

DMF# 2014/008203

Mycophenolate Mofetil

DMF# D21‐3214450

Sevelamer CarbonateDMF# D17/235246
TemozolomideTo be assigned
TeriflunomideDMF# 17-0253
MifepristoneDMF# E24-435676-e008015-0001

New Zealand DMF (total 3)

SubstanceDMF number
LeflunomideTT60-905-18/1
ParicalcitolTT60-905-18-3
Pazopanib HydrochlorideTT60-908-18-6

Russia DMF (total 5)

SubstanceDMF number
AlfacalcidolTo be assigned
LeflunomideLSR-005818/09 - 281215
TemozolomideFS-000605 - 240317
TeriflunomideTo be assigned
Mycophenolate MofetilFS-000467 - 170417

China DMF (total 18)

SubstanceDMF number
AlfacalcidolY20230000706
BenzonatateY20190000653
Calcipotriol AnhydrousY20170001615
Calcipotriol MonohydrateY20200000431
CalcitriolY20190021431
CapsaicinY20230000171
Colesevelam HydrochlorideY20190000469
DOTAF20200000529
Flupentixol DihydrochlorideJXHL1300425國
Gadoterate MeglumineY20230000384
LinezolidY20190000467
Melitracen HydrochlorideJXHL1300424國
Montelukast SodiumY20170001580
ParicalcitolY20180000002
Pazopanib HydrochlorideY20190021452
Sevelamer CarbonateY20180001514
Y20220001209
TemozolomideY20170000140

Singapore DMF (total 6)

SubstanceDMF number
Benzonatate015:1425
Montelukast Sodium015:937
Pazopanib Hydrochloride015:1688
Sevelamer Carbonate015:1240
015:1535
Temozolomide015:831

Korea DMF (total 13)

SubstanceDrug Application Number
Calcitriol20200019466
Mycophenolate Mofetil20210721-209-J-924
Temozolomide20140155951
Balsalazide Disodium Dihydrate20140087156
Benzonatate20220503-209-J-1282
Paricalcitol20151218-198-I-467-04
Levonorgestrel20170220218
Pazopanib Hydrochloride20200107804
Gimeracil20140231270
Oteracil Potassium20140230970
Tegafur20190192649
Sevelamer Carbonate20180304252
20191213-209-J-352(A)
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