US DMF (total 49)

SubstanceDMF number
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 15)

SubstanceDMF number
AlfacalcidolItaly: # 8906.13235.405
Greece: # 791
CapsaicinGreece: # 1714
DE: #3723
UK: MFD-31818-1-06807
ES: AA/01334/18
Colesevelam HydrochlorideUK: # MFD-31818-2-07236
DE: #4427
Gadoterate MeglumineDE: #4616
GR: #3768
LinezolidAT: #551157
CZ: sukls20988/2015
DE: #3266
DK: #2215-2184
ES: AA/0128/13 ; AA/0111/14
FR: #2013-081 ; #2014-038
HR: # 530-09/13-12/83
IT: AIN/2014/20 ; AIN/2017/1445
NL: #02793
PL: UR.DOL.OLC.4003.0302.2014 ; UR.DOL.OLC.4003.0028.2015
UK: MFD-31818-1-00575-0003
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
Nintedanib EsylateDE: #4839
NL: #04351
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-31818-1-02752-0001
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

Pazopanib Hydrochloride

CZ: sukls314155/2020
DE: #4526
ES: #AA/0167/20
GR: #3690
IT: AIN/2020/2469
LA: 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

Sevelamer Carbonate

AT: #550953
BE: #154182
CZ: Sukls213208/2018
DE: #3095
DK: #2215-1765
ES: CS/3324/12
FR: #2021-068
GR: 91008/30-09-2021
HU: OGY/33444-1/2010
HR: #530-09/13-12/67
IT: AIN/2016/612
NL: #02651
PL: UR.DOL.OLC.4003.0224.2017
SE: #2012/090
UK: MFD-31818-2-14239-0003

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


 

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 12)

SubstanceDMF number
Calcipotriol Anhydrous2013-137
Calcitriol2001-124
Capsaicin2016-181
Colesevelam Hydrochloride2021-054
Leflunomide2003-135
Linezolid2013-118
Pazopanib Hydrochloride2021-104
Sevelamer Carbonate2017-009
2021-122
Sevelamer Hydrochloride2021-083
Temozolomide2014-124
Teriflunomide2018-236

 

Australia DMF (total 5)

SubstanceDMF number
Linezolid

DMF #2014/001920

Montelukast Sodium

DMF #2014/008203

Mycophenolate Mofetil

DMF #D21‐3214450

Sevelamer CarbonateDMF# 17-0072
TeriflunomideDMF# 17-0253

 

New Zealand DMF (total 2)

SubstanceDMF number
LeflunomideTT60-905-18/1
ParicalcitolTT60-905-18-3

 

Russia DMF (total 3)

SubstanceDMF number
LeflunomideLSR-005818/09
TemozolomideFC-000605
Mycophenolate MofetilFC-000467

 

China DMF (total 16)

SubstanceDMF number
AlfacalcidolY20170000266
BenzonatateY20190000653
Calcipotriol AnhydrousY20170001615
Calcipotriol MonohydrateY20200000431
CalcitriolY20190021431
CapsaicinY20220000873
Colesevelam HydrochlorideY20190000469
Flupentixol DihydrochlorideJXHL1300425國
Gadoterate MeglumineY20200000802
LinezolidY20190000467
Melitracen HydrochlorideJXHL1300424國
Montelukast SodiumY20170001580
ParicalcitolY20180000002
Pazopanib HydrochlorideY20190021452
Sevelamer CarbonateY20180001514
TemozolomideY20170000140

 

Singapore DMF (total 5)

SubstanceDMF number
Benzonatate38:45:00
Montelukast Sodium30:37:00
Pazopanib Hydrochloride43:08:00
Sevelamer Carbonate35:40:00
Temozolomide28:51:00
Close