US DMF (total 51)

Substance DMF number
Abemaciclib DMF # 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
Capivasertib DMF # 043325; date of submission: Jan. 08, 2026
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
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
Zavegepant Hydrochloride DMF # 042914; date of submission: Nov. 28, 2025

 

CEP (total 8)

Substance CEP number
Calcifediol Monohydrate CEP2019-163
Calcipotriol Anhydrous CEP2007-243
Calcipotriol Monohydrate CEP2010-187
Calcitriol CEP2009-377
CEP2020-150
Leflunomide CEP2009-035
Montelukast Sodium CEP2013-278
Temozolomide CEP2017-245

 

EU DMF (total 20)

Substance DMF number
Alfacalcidol Italy: # 8906.132.35.405
Greece: # 791
Anastrozole CZ: 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
Calcitriol GR: 792
IT: 8906.130.67.799
Capsaicin Greece: # 1714
DE: #3723
ES: AA/01334/18
Colesevelam Hydrochloride UK: # MFD-31818-2-07236
DE: #4427
Eribulin Mesylate DE: 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 Meglumine DE: #4616
GR: #3768
Linezolid AT: #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
Mifepristone ASMF No.: EU/ASMF/00778
Montelukast Sodium AT: #551116
CZ: # sukls10917/2014
HR: #530-09/13-12/90
NL: #021165
UK: # MFD-31818-2-07158
Mycophenolate Mofetil DE: #4599
UK: MFD-31818-2-07706
MT: To be assigned
Nintedanib Esylate DE: #4839
NL: #04351
GR: 3942
CY: To be assigned
HU: To be assigned
Orlistat AT: 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 Hydrochloride CZ: 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)

Substance DMF number
Alfacalcidol 302MF10045
Gadodiamide 220MF10205
Tegaful 224MF10136
Gimeracil 224MF10135
Oteracil Potassium 224MF10134
Taltirelin Hydrate 224MF10029
303MF10035
Linezolid

225MF10170
226MF10166 (oral)
302MF10099
Maxacalcitol 226MF10138
Temozolomide 228MF10143
Levonorgestrel 228MF10159
Calcitriol 228MF10187

 

Canada DMF (total 11)

Substance DMF number
Calcitriol 2001-124
Capsaicin 2016-181
Colesevelam Hydrochloride 2021-054
Leflunomide 2003-135
Linezolid 2013-118
Mifepristone 2024-067
Pazopanib Hydrochloride 2021-104
Sevelamer Carbonate 2017-009
2021-122
Sevelamer Hydrochloride 2021-083
Teriflunomide 2018-236

 

Australia DMF (total 8)

Substance DMF number
Calcipotriol monohydrate To be assigned
Linezolid

DMF# 2014/001920
Montelukast Sodium

DMF# 2014/008203
Mycophenolate Mofetil

DMF# D21‐3214450
Sevelamer Carbonate DMF# D17/235246
Temozolomide To be assigned
Teriflunomide DMF# 17-0253
Mifepristone DMF# E24-435676-e008015-0001

New Zealand DMF (total 3)

Substance DMF number
Leflunomide TT60-905-18/1
Paricalcitol TT60-905-18-3
Pazopanib Hydrochloride TT60-908-18-6

Russia DMF (total 5)

Substance DMF number
Alfacalcidol To be assigned
Leflunomide LSR-005818/09 - 281215
Temozolomide FS-000605 - 240317
Teriflunomide To be assigned
Mycophenolate Mofetil FS-000467 - 170417

China DMF (total 18)

Substance DMF number
Alfacalcidol Y20230000706
Benzonatate Y20190000653
Calcipotriol Anhydrous Y20170001615
Calcipotriol Monohydrate Y20200000431
Calcitriol Y20190021431
Capsaicin Y20230000171
Colesevelam Hydrochloride Y20190000469
DOTA F20200000529
Flupentixol Dihydrochloride JXHL1300425國
Gadoterate Meglumine Y20230000384
Linezolid Y20190000467
Melitracen Hydrochloride JXHL1300424國
Montelukast Sodium Y20170001580
Paricalcitol Y20180000002
Pazopanib Hydrochloride Y20190021452
Sevelamer Carbonate Y20180001514
Y20220001209
Temozolomide Y20170000140

Singapore DMF (total 6)

Substance DMF number
Benzonatate 015:1425
Montelukast Sodium 015:937
Pazopanib Hydrochloride 015:1688
Sevelamer Carbonate 015:1240
015:1535
Temozolomide 015:831

Korea DMF (total 13)

Substance Drug Application Number
Calcitriol 20200019466
Mycophenolate Mofetil 20210721-209-J-924
Temozolomide 20140155951
Balsalazide Disodium Dihydrate 20140087156
Benzonatate 20220503-209-J-1282
Paricalcitol 20151218-198-I-467-04
Levonorgestrel 20170220218
Pazopanib Hydrochloride 20200107804
Gimeracil 20140231270
Oteracil Potassium 20140230970
Tegafur 20190192649
Sevelamer Carbonate 20180304252
20191213-209-J-352(A)
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