Athena Athena

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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Royal DSM

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Royal DSM
Netherlands1 Flag
Country
Country
Netherlands
Address
Address
Het Overloon 1, 6411 TE Heerlen
Telephone
Telephone
+31 45 578 8111

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USDMF

Found USDMF

30618
Active
ASCORBIC ACID
2016-07-05
CEP/COS

Found CEP/COS

R1-CEP 1996-078 - Rev 05
Valid
Ascorbic acid
2022-09-29
Japanese DMF

Found JDMF

225MF10007
Ascorbic acid ultrafine powder Asco...
2013-01-18
Written Confirmation

Close WC

Application Number
30618
225MF10007
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
ASCORBIC ACID
Ascorbic acid
Ascorbic acid ultrafine powder Asco...
Issue/Submission Date
2016-07-05
2022-09-29
2013-01-18
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USDMF

Found USDMF

30157
Active
BIOTIN
2016-01-13
CEP/COS

Found CEP/COS

R1-CEP 2001-405 - Rev 05
Valid
Biotin
2023-01-16
Japanese DMF

Found JDMF

217MF11122
Biotin Biotin at Wurmisweg 576, CH-...
2005-12-05
Written Confirmation

Close WC

Application Number
30157
217MF11122
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
BIOTIN
Biotin
Biotin Biotin at Wurmisweg 576, CH-...
Issue/Submission Date
2016-01-13
2023-01-16
2005-12-05
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USDMF

Found USDMF

30723
Active
DEXPANTHENOL
2016-09-02
CEP/COS

Found CEP/COS

R1-CEP 1997-113 - Rev 03
Valid
Dexpanthenol
2021-04-22
Japanese DMF

Found JDMF

217MF11287
Panthenol D-Panthenol at Wurmisweg ...
2005-12-22
Written Confirmation

Close WC

Application Number
30723
217MF11287
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
DEXPANTHENOL
Dexpanthenol
Panthenol D-Panthenol at Wurmisweg ...
Issue/Submission Date
2016-09-02
2021-04-22
2005-12-22
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USDMF

Found USDMF

30651
Active
FOLIC ACID
2016-07-05
CEP/COS

Found CEP/COS

R1-CEP 1996-045 - Rev 06
Valid
Folic acid hydrate
2023-08-10
Japanese DMF

Found JDMF

218MF10102
Folic Acid Folic Acid at Wurmisweg ...
2006-01-30
Written Confirmation

Close WC

Application Number
30651
218MF10102
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
FOLIC ACID
Folic acid hydrate
Folic Acid Folic Acid at Wurmisweg ...
Issue/Submission Date
2016-07-05
2023-08-10
2006-01-30
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USDMF

Found USDMF

36386
Active
PYRIDOXINE HYDROCHLORIDE
2021-12-01
CEP/COS

Found CEP/COS

R1-CEP 2017-027 - Rev 00
Valid
Pyridoxine hydrochloride
2023-08-07
Japanese DMF

Found JDMF

230MF10050
Japanese Pharmacopoeia pyridoxine h...
2018-04-04
Written Confirmation

Close WC

Application Number
36386
230MF10050
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
PYRIDOXINE HYDROCHLORIDE
Pyridoxine hydrochloride
Japanese Pharmacopoeia pyridoxine h...
Issue/Submission Date
2021-12-01
2023-08-07
2018-04-04
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USDMF

Found USDMF

30634
Active
THIAMINE HYDROCHLORIDE
2016-06-29
CEP/COS

Found CEP/COS

R1-CEP 1998-131 - Rev 05
Valid
Thiamine hydrochloride
2021-04-20
Japanese DMF

Found JDMF

219MF10116
Japanese Pharmacopoeia thiamine chl...
2007-03-23
Written Confirmation

Close WC

Application Number
30634
219MF10116
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
THIAMINE HYDROCHLORIDE
Thiamine hydrochloride
Japanese Pharmacopoeia thiamine chl...
Issue/Submission Date
2016-06-29
2021-04-20
2007-03-23
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USDMF

Found USDMF

21048
Active
Cholecalciferol (Vitamin D3)
2007-11-19
CEP/COS

Found CEP/COS

R0-CEP 2019-003 - Rev 00
Valid
Cholecalciferol concentrate (powder...
2020-11-23
Japanese DMF

Found JDMF

223MF10101
Cholecalciferol Cholecalciferol / V...
2011-07-11
Written Confirmation

Close WC

Application Number
21048
223MF10101
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
Cholecalciferol (Vitamin D3)
Cholecalciferol concentrate (powder...
Cholecalciferol Cholecalciferol / V...
Issue/Submission Date
2007-11-19
2020-11-23
2011-07-11
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USDMF

Found USDMF

30673
Active
DL-ALPHA-TOCOPHERYL ACETATE
2016-07-21
CEP/COS

Found CEP/COS

R0-CEP 2019-086 - Rev 00
Valid
alpha-Tocopheryl acetate concentrat...
2021-03-04
Japanese DMF

Found JDMF

219MF10115
Japanese Pharmacopoeia tocopherol a...
2007-03-23
Written Confirmation

Close WC

Application Number
30673
219MF10115
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
DL-ALPHA-TOCOPHERYL ACETATE
alpha-Tocopheryl acetate concentrat...
Japanese Pharmacopoeia tocopherol a...
Issue/Submission Date
2016-07-21
2021-03-04
2007-03-23
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USDMF

Found USDMF

24530
Active
PHYTOMENADIONE (VITAMIN K1)
2011-01-05
CEP/COS

Found CEP/COS

R1-CEP 2003-085 - Rev 06
Valid
all-rac-Phytomenadione
2022-01-24
Japanese DMF

Found JDMF

218MF10101
Phytonadione Phytonadione / Vitamin...
2006-01-30
Written Confirmation

Close WC

Application Number
24530
218MF10101
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
PHYTOMENADIONE (VITAMIN K1)
all-rac-Phytomenadione
Phytonadione Phytonadione / Vitamin...
Issue/Submission Date
2011-01-05
2022-01-24
2006-01-30
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USDMF

Found USDMF

32157
Active
AMOXICILLIN TRIHYDRATE - PURIMOX®
2017-12-22
CEP/COS

Found CEP/COS

R0-CEP 2018-178 - Rev 01
Valid
Amoxicillin trihydrate
2020-08-19
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
32157
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
AMOXICILLIN TRIHYDRATE - PURIMOX®
Amoxicillin trihydrate
Issue/Submission Date
2017-12-22
2020-08-19
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USDMF

Found USDMF

13777
Active
AMPICILLIN ANHYDROUS
1998-09-01
CEP/COS

Found CEP/COS

R2-CEP 1995-031 - Rev 05
Valid
Ampicillin, Mexico
2022-02-21
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
13777
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
AMPICILLIN ANHYDROUS
Ampicillin, Mexico
Issue/Submission Date
1998-09-01
2022-02-21
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USDMF

Found USDMF

13426
Active
AMPICILLIN TRIHYDRATE
1998-09-01
CEP/COS

Found CEP/COS

R2-CEP 1995-029 - Rev 05
Valid
Ampicillin trihydrate, Mexico ; pow...
2022-01-05
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
13426
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
AMPICILLIN TRIHYDRATE
Ampicillin trihydrate, Mexico ; pow...
Issue/Submission Date
1998-09-01
2022-01-05
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2001-272 - Rev 05
Valid
Benzylpenicillin potassium
2018-11-13
Japanese DMF

Found JDMF

229MF10121
Benzylpenicillin Potassium at Carre...
2017-07-11
Written Confirmation

Close WC

Application Number
229MF10121
Status
Valid
 
Filing Details
Benzylpenicillin potassium
Benzylpenicillin Potassium at Carre...
Issue/Submission Date
2018-11-13
2017-07-11
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2009-091 - Rev 01
Valid
Flucytosine
2022-01-11
Japanese DMF

Found JDMF

222MF10042
Flucytosine at Wurmisweg 576, CH-43...
2010-02-04
Written Confirmation

Close WC

Application Number
222MF10042
Status
Valid
 
Filing Details
Flucytosine
Flucytosine at Wurmisweg 576, CH-43...
Issue/Submission Date
2022-01-11
2010-02-04
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 1998-099 - Rev 02
Valid
Pyridoxine hydrochloride
2009-10-15
Japanese DMF

Found JDMF

219MF10118
Japanese Pharmacopoeia pyridoxine h...
2007-03-23
Written Confirmation

Close WC

Application Number
219MF10118
Status
Valid
 
Filing Details
Pyridoxine hydrochloride
Japanese Pharmacopoeia pyridoxine h...
Issue/Submission Date
2009-10-15
2007-03-23
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2000-088 - Rev 01
Valid
Riboflavin, Fermentation process
2007-10-22
Japanese DMF

Found JDMF

217MF11283
Riboflavin Riboflavin Universal at ...
2005-12-22
Written Confirmation

Close WC

Application Number
217MF11283
Status
Valid
 
Filing Details
Riboflavin, Fermentation process
Riboflavin Riboflavin Universal at ...
Issue/Submission Date
2007-10-22
2005-12-22
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USDMF

Found USDMF

30831
Active
RIBOFLAVIN 5-PHOSPHATE SODIUM
2016-09-07
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

219MF10120
Japanese Pharmacopoeia riboflavin p...
2007-03-23
Written Confirmation

Close WC

Application Number
30831
219MF10120
Status
Active
Fees Paid
Reviewed
 
Filing Details
RIBOFLAVIN 5-PHOSPHATE SODIUM
Japanese Pharmacopoeia riboflavin p...
Issue/Submission Date
2016-09-07
2007-03-23
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USDMF

Found USDMF

31184
Active
SODIUM ASCORBATE
2016-12-21
CEP/COS

Found CEP/COS

R1-CEP 2002-254 - Rev 04
Valid
Sodium ascorbate
2021-12-17
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
31184
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
SODIUM ASCORBATE
Sodium ascorbate
Issue/Submission Date
2016-12-21
2021-12-17
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 1999-057 - Rev 05
Valid
Thiamine nitrate
2021-04-26
Japanese DMF

Found JDMF

219MF10117
Japanese Pharmacopoeia thiamine nit...
2007-03-23
Written Confirmation

Close WC

Application Number
219MF10117
Status
Valid
 
Filing Details
Thiamine nitrate
Japanese Pharmacopoeia thiamine nit...
Issue/Submission Date
2021-04-26
2007-03-23
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2004-301 - Rev 01
Valid
Vitamin A, Not less than 1.7 MIU/g,...
2021-09-10
Japanese DMF

Found JDMF

217MF11120
Vitamin A oil Vitamin A Oil at Haup...
2005-12-05
Written Confirmation

Close WC

Application Number
217MF11120
Status
Valid
 
Filing Details
Vitamin A, Not less than 1.7 MIU/g,...
Vitamin A oil Vitamin A Oil at Haup...
Issue/Submission Date
2021-09-10
2005-12-05
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R0-CEP 2021-139 - Rev 00
Valid
Vitamin A concentrate (powder form)...
2023-01-11
Japanese DMF

Found JDMF

219MF10121
Japanese Pharmacopoeia vitamin A oi...
2007-03-23
Written Confirmation

Close WC

Application Number
219MF10121
Status
Valid
 
Filing Details
Vitamin A concentrate (powder form)...
Japanese Pharmacopoeia vitamin A oi...
Issue/Submission Date
2023-01-11
2007-03-23
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2005-069 - Rev 01
Valid
Vitamin A, Not less than 2.8 MIU/g ...
2021-07-12
Japanese DMF

Found JDMF

224MF10063
Dry vitamin A acetate, type 500B Dr...
2012-04-01
Written Confirmation

Close WC

Application Number
224MF10063
Status
Valid
 
Filing Details
Vitamin A, Not less than 2.8 MIU/g ...
Dry vitamin A acetate, type 500B Dr...
Issue/Submission Date
2021-07-12
2012-04-01
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USDMF

Found USDMF

31038
Active
VITAMIN A PALMITATE 1.7 MIU/G (WITH...
2016-10-28
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

219MF10114
Japanese Pharmacopoeia Retinol palm...
2007-03-23
Written Confirmation

Close WC

Application Number
31038
219MF10114
Status
Active
Fees Paid
Reviewed
 
Filing Details
VITAMIN A PALMITATE 1.7 MIU/G (WITH...
Japanese Pharmacopoeia Retinol palm...
Issue/Submission Date
2016-10-28
2007-03-23
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USDMF

Found USDMF

30832
Active
CHOLECALCIFEROL (VITAMIN D3)
2016-09-20
CEP/COS

Found CEP/COS

R0-CEP 2021-055 - Rev 00
Valid
Cholecalciferol concentrate (oily f...
2022-11-16
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
30832
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
CHOLECALCIFEROL (VITAMIN D3)
Cholecalciferol concentrate (oily f...
Issue/Submission Date
2016-09-20
2022-11-16
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USDMF

Found USDMF

37963
Active
LIQUID VITAMIN D3 IN CORN OIL
2023-06-29
CEP/COS

Found CEP/COS

R1-CEP 2015-199 - Rev 00
Valid
Cholecalciferol concentrate (powder...
2021-09-03
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
37963
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
LIQUID VITAMIN D3 IN CORN OIL
Cholecalciferol concentrate (powder...
Issue/Submission Date
2023-06-29
2021-09-03
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R0-CEP 2019-164 - Rev 00
Valid
all-rac-alpha-Tocopherol
2021-02-11
Japanese DMF

Found JDMF

227MF10023
Dry Vitamin E50%, type SD / Dry Vit...
2015-01-23
Written Confirmation

Close WC

Application Number
227MF10023
Status
Valid
 
Filing Details
all-rac-alpha-Tocopherol
Dry Vitamin E50%, type SD / Dry Vit...
Issue/Submission Date
2021-02-11
2015-01-23
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2001-180 - Rev 01
Valid
all-rac-alpha-Tocopheryl acetate
2019-05-03
Japanese DMF

Found JDMF

217MF11121
Tocopherol acetate dl-α -Tocophery...
2005-12-05
Written Confirmation

Close WC

Application Number
217MF11121
Status
Valid
 
Filing Details
all-rac-alpha-Tocopheryl acetate
Tocopherol acetate dl-α -Tocophery...
Issue/Submission Date
2019-05-03
2005-12-05
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NA Not Available For Sales
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

218MF11023
Aprotinin concentrate (production o...
2006-12-28
Written Confirmation

Close WC

Application Number
218MF11023
Status
 
Filing Details
Aprotinin concentrate (production o...
Issue/Submission Date
2006-12-28
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

228MF10181
Aprotinin concentrated solution at ...
2016-09-08
Written Confirmation

Close WC

Application Number
228MF10181
Status
 
Filing Details
Aprotinin concentrated solution at ...
Issue/Submission Date
2016-09-08
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

218MF10551
Ascorbic Sancti type EC Coated Asco...
2006-06-02
Written Confirmation

Close WC

Application Number
218MF10551
Status
 
Filing Details
Ascorbic Sancti type EC Coated Asco...
Issue/Submission Date
2006-06-02
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

219MF10043
Sodium ascorbate crystals Sodium As...
2007-02-13
Written Confirmation

Close WC

Application Number
219MF10043
Status
 
Filing Details
Sodium ascorbate crystals Sodium As...
Issue/Submission Date
2007-02-13
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2002-255 - Rev 00
Valid
Ascorbyl palmitate
2008-09-08
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
Status
Valid
 
Filing Details
Ascorbyl palmitate
Issue/Submission Date
2008-09-08
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2010-383 - Rev 01
Valid
Betacarotene
2019-06-14
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
Status
Valid
 
Filing Details
Betacarotene
Issue/Submission Date
2019-06-14
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

217MF11286
Calcium pantothenate Calcium D-Pant...
2005-12-22
Written Confirmation

Close WC

Application Number
217MF11286
Status
 
Filing Details
Calcium pantothenate Calcium D-Pant...
Issue/Submission Date
2005-12-22
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USDMF

Found USDMF

28945
Active
COLESEVELAM HYDROCHLORIDE
2014-12-19
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
28945
Status
Active
Fees Paid
Reviewed
 
Filing Details
COLESEVELAM HYDROCHLORIDE
Issue/Submission Date
2014-12-19
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NA Not Available For Sales
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2004-044 - Rev 01
Valid
Collagen, Semed F
2013-05-27
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
Status
Valid
 
Filing Details
Collagen, Semed F
Issue/Submission Date
2013-05-27
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2004-046 - Rev 01
Valid
Collagen, Semed S
2013-05-27
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Collagen, Semed S
Issue/Submission Date
2013-05-27
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USDMF

Found USDMF

395
Active
5% D-METHORPHAN HYDROBROMIDE ADSORB...
1960-08-10
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
395
Status
Active
Fees Paid
N/A
 
Filing Details
5% D-METHORPHAN HYDROBROMIDE ADSORB...
Issue/Submission Date
1960-08-10
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USDMF

Found USDMF

37097
Active
EPA 670 ETHYL ESTER INTERMEDIATE (I...
2022-07-15
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
37097
Status
Active
Fees Paid
N/A
 
Filing Details
EPA 670 ETHYL ESTER INTERMEDIATE (I...
Issue/Submission Date
2022-07-15
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USDMF

Found USDMF

25420
Active
HIGH EPA INTERMEDIATE FISH OIL
2011-11-22
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
25420
Status
Active
Fees Paid
N/A
 
Filing Details
HIGH EPA INTERMEDIATE FISH OIL
Issue/Submission Date
2011-11-22
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USDMF

Found USDMF

24760
Active
NEOSTIGMINE METHYLSULFATE
2011-03-16
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
24760
Status
Active
Fees Paid
Reviewed
 
Filing Details
NEOSTIGMINE METHYLSULFATE
Issue/Submission Date
2011-03-16
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2004-267 - Rev 02
Valid
Calcium Pantothenate
2019-08-13
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Calcium Pantothenate
Issue/Submission Date
2019-08-13
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USDMF

Found USDMF

13724
Active
PENICILLIN G POTASSIUM
1998-09-01
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
13724
Status
Active
Fees Paid
N/A
 
Filing Details
PENICILLIN G POTASSIUM
Issue/Submission Date
1998-09-01
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USDMF

Found USDMF

10593
Active
PYRIDOSTIGMINE BROMIDE
1993-11-30
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
10593
Status
Active
Fees Paid
N/A
 
Filing Details
PYRIDOSTIGMINE BROMIDE
Issue/Submission Date
1993-11-30
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USDMF

Found USDMF

27710
Active
SILVER SULFADAZINE
2013-11-11
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
27710
Status
Active
Fees Paid
N/A
 
Filing Details
SILVER SULFADAZINE
Issue/Submission Date
2013-11-11
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USDMF

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CEP/COS

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Japanese DMF

Found JDMF

218MF10553
Dry Vitamin A Acetate, type 500 Dry...
2006-06-02
Written Confirmation

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Application Number
218MF10553
Status
 
Filing Details
Dry Vitamin A Acetate, type 500 Dry...
Issue/Submission Date
2006-06-02
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USDMF

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CEP/COS

Found CEP/COS

R0-CEP 2019-351 - Rev 00
Valid
Cholecalciferol, Site Sisseln
2020-05-18
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Cholecalciferol, Site Sisseln
Issue/Submission Date
2020-05-18
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USDMF

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CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

218MF10552
Dry Vitamin E50%, type SD Dry Vitam...
2006-06-02
Written Confirmation

Close WC

Application Number
218MF10552
Status
 
Filing Details
Dry Vitamin E50%, type SD Dry Vitam...
Issue/Submission Date
2006-06-02
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RIBOFLAVIN 5' PHOSPHATE SODIUM (PROCESS II)

URL Supplier Web Content
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USDMF

Found USDMF

39297
Active
RIBOFLAVIN 5' PHOSPHATE SODIUM (PRO...
2023-12-21
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
39297
Status
Active
Fees Paid
N/A
 
Filing Details
RIBOFLAVIN 5' PHOSPHATE SODIUM (PRO...
Issue/Submission Date
2023-12-21
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Hemokoaguraze solution

URL Supplier Web Content
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

221MF10043
Hemokoaguraze solution at Dornacher...
2009-02-25
Written Confirmation

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Application Number
221MF10043
Status
 
Filing Details
Hemokoaguraze solution at Dornacher...
Issue/Submission Date
2009-02-25
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