Athena Athena

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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Lonza Capsugel

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Lonza Capsugel
United_States_of_America Flag
Country
Country
U.S.A
Address
Address
412, Mt. Kemble Ave Suite 200S, Morristown, NJ 07960
Telephone
Telephone
201-316-9200

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USDMF

Caution USDMF

8041
Inactive
NIACIN USP SPECIAL
1989-04-14
CEP/COS

Found CEP/COS

R1-CEP 2007-268 - Rev 00
Valid
Nicotinic Acid, Material number 513...
2014-02-25
Japanese DMF

Found JDMF

218MF10930
Niacin USP Special at Muenchenstein...
2006-11-21
Written Confirmation

Close WC

Application Number
8041
218MF10930
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
NIACIN USP SPECIAL
Nicotinic Acid, Material number 513...
Niacin USP Special at Muenchenstein...
Issue/Submission Date
1989-04-14
2014-02-25
2006-11-21
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USDMF

Caution USDMF

11119
Inactive
NIACINAMIDE
1994-09-21
CEP/COS

Found CEP/COS

CEP 2004-110 - Rev 06
Valid
Nicotinamide
2023-09-28
Japanese DMF

Found JDMF

226MF10200
Nicotinic acid amide at 68, Huangge...
2014-10-27
Written Confirmation

Close WC

Application Number
11119
226MF10200
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
NIACINAMIDE
Nicotinamide
Nicotinic acid amide at 68, Huangge...
Issue/Submission Date
1994-09-21
2023-09-28
2014-10-27
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USDMF

Found USDMF

25201
Active
FLUVOXAMINE MALEATE (SV-006)
2011-08-05
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

223MF10056
Fluvoxamine maleate at Muenchenstei...
2011-04-21
Written Confirmation

Close WC

Application Number
25201
223MF10056
Status
Active
Fees Paid
N/A
 
Filing Details
FLUVOXAMINE MALEATE (SV-006)
Fluvoxamine maleate at Muenchenstei...
Issue/Submission Date
2011-08-05
2011-04-21
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USDMF

Found USDMF

30711
Active
NIACINAMIDE FOR ORAL USE
2016-06-13
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

219MF10271
Nicotinic acid amide at 39 Jinhui R...
2007-09-04
Written Confirmation

Close WC

Application Number
30711
219MF10271
Status
Active
Fees Paid
Reviewed
 
Filing Details
NIACINAMIDE FOR ORAL USE
Nicotinic acid amide at 39 Jinhui R...
Issue/Submission Date
2016-06-13
2007-09-04
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USDMF

Caution USDMF

7493
Inactive
DESMOPRESSIN ACETATE
1988-04-30
CEP/COS

Found CEP/COS

R1-CEP 2003-208 - Rev 01
Valid
Desmopressin, Liquid phase synthesi...
2011-03-04
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
7493
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
DESMOPRESSIN ACETATE
Desmopressin, Liquid phase synthesi...
Issue/Submission Date
1988-04-30
2011-03-04
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USDMF

Caution USDMF

18293
Inactive
NIACIN USP GRANULAR SPECIAL
2005-04-11
CEP/COS

Found CEP/COS

R1-CEP 2006-215 - Rev 00
Valid
Nicotinic Acid, Product code 51 337
2012-10-08
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
18293
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
NIACIN USP GRANULAR SPECIAL
Nicotinic Acid, Product code 51 337
Issue/Submission Date
2005-04-11
2012-10-08
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2000-294 - Rev 02
Valid
Foetal Bovine Serum
2007-04-23
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
Status
Valid
 
Filing Details
Foetal Bovine Serum
Issue/Submission Date
2007-04-23
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2001-196 - Rev 01
Valid
Calf Serum
2007-04-23
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
Status
Valid
 
Filing Details
Calf Serum
Issue/Submission Date
2007-04-23
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2001-181 - Rev 00
Valid
Newborn Calf Serum, Product code: 1...
2007-06-29
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
Status
Valid
 
Filing Details
Newborn Calf Serum, Product code: 1...
Issue/Submission Date
2007-06-29
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USDMF

Found USDMF

17117
Active
DEXMETHYLPHENIDATE HYDROCHLORIDE (D...
2004-01-23
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
17117
Status
Active
Fees Unpaid
N/A
 
Filing Details
DEXMETHYLPHENIDATE HYDROCHLORIDE (D...
Issue/Submission Date
2004-01-23
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

221MF10097
Eculizumab at 101 International Dri...
2009-05-21
Written Confirmation

Close WC

Application Number
221MF10097
Status
 
Filing Details
Eculizumab at 101 International Dri...
Issue/Submission Date
2009-05-21
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USDMF

Found USDMF

11932
Active
DL-2-(DIFLUOROMETHYL) ORNITHINE MON...
1996-04-17
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
11932
Status
Active
Fees Paid
N/A
 
Filing Details
DL-2-(DIFLUOROMETHYL) ORNITHINE MON...
Issue/Submission Date
1996-04-17
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

224MF10088
Ofatumumab at 101 International Dri...
2012-04-25
Written Confirmation

Close WC

Application Number
224MF10088
Status
 
Filing Details
Ofatumumab at 101 International Dri...
Issue/Submission Date
2012-04-25
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

218MF10401
hP67.6 antibody at 228 Bath Road, S...
2006-04-14
Written Confirmation

Close WC

Application Number
218MF10401
Status
 
Filing Details
hP67.6 antibody at 228 Bath Road, S...
Issue/Submission Date
2006-04-14
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USDMF

Found USDMF

19813
Active
SIROLIMUS
2006-09-28
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
19813
Status
Active
Fees Paid
N/A
 
Filing Details
SIROLIMUS
Issue/Submission Date
2006-09-28
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USDMF

Found USDMF

33779
Active
VOCLOSPORIN
2020-04-06
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
33779
Status
Active
Fees Paid
N/A
 
Filing Details
VOCLOSPORIN
Issue/Submission Date
2020-04-06
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

305MF10058
Voclosporin at Muenchensteiner stra...
2023-05-10
Written Confirmation

Close WC

Application Number
305MF10058
Status
 
Filing Details
Voclosporin at Muenchensteiner stra...
Issue/Submission Date
2023-05-10
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HOST CELL LINES CHO-K1, CHOK1SV AND CHOK1SV GS-KO

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USDMF

Found USDMF

35327
Active
HOST CELL LINES CHO-K1, CHOK1SV AND...
2021-01-27
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
35327
Status
Active
Fees Paid
N/A
 
Filing Details
HOST CELL LINES CHO-K1, CHOK1SV AND...
Issue/Submission Date
2021-01-27
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HOST CELL LINE NS0

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USDMF

Found USDMF

35328
Active
HOST CELL LINE NS0
2021-01-27
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
35328
Status
Active
Fees Paid
N/A
 
Filing Details
HOST CELL LINE NS0
Issue/Submission Date
2021-01-27
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EC-125 DRUG SUBSTANCE

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USDMF

Found USDMF

21515
Active
EC-125 DRUG SUBSTANCE
2008-04-07
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
21515
Status
Active
Fees Paid
N/A
 
Filing Details
EC-125 DRUG SUBSTANCE
Issue/Submission Date
2008-04-07
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MC-VAL-ALA-PBD

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USDMF

Found USDMF

30284
Active
MC-VAL-ALA-PBD
2016-02-19
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
30284
Status
Active
Fees Paid
N/A
 
Filing Details
MC-VAL-ALA-PBD
Issue/Submission Date
2016-02-19
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Medium / Medium Additive / SF72 Feed Medium

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

303MF40038
Medium / Medium Additive / SF72 Fee...
2021-07-01
Written Confirmation

Close WC

Application Number
303MF40038
Status
 
Filing Details
Medium / Medium Additive / SF72 Fee...
Issue/Submission Date
2021-07-01
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Medium / Medium Additive / NM16 Growth Medium

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

303MF40035
Medium / Medium Additive / NM16 Gro...
2021-06-15
Written Confirmation

Close WC

Application Number
303MF40035
Status
 
Filing Details
Medium / Medium Additive / NM16 Gro...
Issue/Submission Date
2021-06-15
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Medium / medium additive ・ NM30. SPE growth medium

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

303MF40036
Medium / medium additive ・ NM30. ...
2021-06-15
Written Confirmation

Close WC

Application Number
303MF40036
Status
 
Filing Details
Medium / medium additive ・ NM30. ...
Issue/Submission Date
2021-06-15
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Medium / medium additive ・ NM20. SPE production cultu...

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

303MF40037
Medium / medium additive ・ NM20. ...
2021-06-15
Written Confirmation

Close WC

Application Number
303MF40037
Status
 
Filing Details
Medium / medium additive ・ NM20. ...
Issue/Submission Date
2021-06-15
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Medium / Medium Additive / CM96 Culture Medium

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

303MF40029
Medium / Medium Additive / CM96 Cul...
2021-06-07
Written Confirmation

Close WC

Application Number
303MF40029
Status
 
Filing Details
Medium / Medium Additive / CM96 Cul...
Issue/Submission Date
2021-06-07
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Medium / Medium Additive / SF70 Feed Medium

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

303MF40030
Medium / Medium Additive / SF70 Fee...
2021-06-07
Written Confirmation

Close WC

Application Number
303MF40030
Status
 
Filing Details
Medium / Medium Additive / SF70 Fee...
Issue/Submission Date
2021-06-07
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Medium / Medium Additive / CM67 Culture Medium

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

303MF40031
Medium / Medium Additive / CM67 Cul...
2021-06-07
Written Confirmation

Close WC

Application Number
303MF40031
Status
 
Filing Details
Medium / Medium Additive / CM67 Cul...
Issue/Submission Date
2021-06-07
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Medium / Medium Additive / CM68 Culture Medium

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

303MF40032
Medium / Medium Additive / CM68 Cul...
2021-06-07
Written Confirmation

Close WC

Application Number
303MF40032
Status
 
Filing Details
Medium / Medium Additive / CM68 Cul...
Issue/Submission Date
2021-06-07
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Medium / medium additive · Lonza Porrino NS0 cell line...

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

228MF40003
Medium / medium additive · Lonza P...
2016-02-18
Written Confirmation

Close WC

Application Number
228MF40003
Status
 
Filing Details
Medium / medium additive · Lonza P...
Issue/Submission Date
2016-02-18
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Medium/medium additive CM76 culture medium_SGTS

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

304MF40039
Medium/medium additive CM76 culture...
2022-12-07
Written Confirmation

Close WC

Application Number
304MF40039
Status
 
Filing Details
Medium/medium additive CM76 culture...
Issue/Submission Date
2022-12-07
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Medium/medium additive CM77 culture medium_SGTS

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

304MF40040
Medium/medium additive CM77 culture...
2022-12-07
Written Confirmation

Close WC

Application Number
304MF40040
Status
 
Filing Details
Medium/medium additive CM77 culture...
Issue/Submission Date
2022-12-07
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Medium / medium additive CM111 culture medium_SGTS

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

304MF40041
Medium / medium additive CM111 cult...
2022-12-07
Written Confirmation

Close WC

Application Number
304MF40041
Status
 
Filing Details
Medium / medium additive CM111 cult...
Issue/Submission Date
2022-12-07
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Medium/medium additive SF71 feed medium_SGTS

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

304MF40042
Medium/medium additive SF71 feed me...
2022-12-07
Written Confirmation

Close WC

Application Number
304MF40042
Status
 
Filing Details
Medium/medium additive SF71 feed me...
Issue/Submission Date
2022-12-07
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Medium/medium additive SF77 feed medium_SGTS

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

304MF40043
Medium/medium additive SF77 feed me...
2022-12-07
Written Confirmation

Close WC

Application Number
304MF40043
Status
 
Filing Details
Medium/medium additive SF77 feed me...
Issue/Submission Date
2022-12-07
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Medium/medium additive SF99 feed medium_SGTS

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

304MF40044
Medium/medium additive SF99 feed me...
2022-12-07
Written Confirmation

Close WC

Application Number
304MF40044
Status
 
Filing Details
Medium/medium additive SF99 feed me...
Issue/Submission Date
2022-12-07
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Medium/medium additive CM78 culture medium_SGTS

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

304MF40045
Medium/medium additive CM78 culture...
2022-12-07
Written Confirmation

Close WC

Application Number
304MF40045
Status
 
Filing Details
Medium/medium additive CM78 culture...
Issue/Submission Date
2022-12-07
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Medium / Medium Additive / CM66 Culture Medium

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

303MF40011
Medium / Medium Additive / CM66 Cul...
2021-04-08
Written Confirmation

Close WC

Application Number
303MF40011
Status
 
Filing Details
Medium / Medium Additive / CM66 Cul...
Issue/Submission Date
2021-04-08
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Medium / Medium Additive / CM76 Culture Medium

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

303MF40012
Medium / Medium Additive / CM76 Cul...
2021-04-08
Written Confirmation

Close WC

Application Number
303MF40012
Status
 
Filing Details
Medium / Medium Additive / CM76 Cul...
Issue/Submission Date
2021-04-08
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Medium / Medium Additive / CM111 Culture Medium

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

303MF40013
Medium / Medium Additive / CM111 Cu...
2021-04-08
Written Confirmation

Close WC

Application Number
303MF40013
Status
 
Filing Details
Medium / Medium Additive / CM111 Cu...
Issue/Submission Date
2021-04-08
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Medium / Medium Additive / CM77 Culture Medium

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

303MF40014
Medium / Medium Additive / CM77 Cul...
2021-04-08
Written Confirmation

Close WC

Application Number
303MF40014
Status
 
Filing Details
Medium / Medium Additive / CM77 Cul...
Issue/Submission Date
2021-04-08
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Medium / Medium Additive / CM78 Culture Medium

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

303MF40015
Medium / Medium Additive / CM78 Cul...
2021-04-08
Written Confirmation

Close WC

Application Number
303MF40015
Status
 
Filing Details
Medium / Medium Additive / CM78 Cul...
Issue/Submission Date
2021-04-08
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Medium / Medium Additive / SF99 Feed Medium

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

303MF40016
Medium / Medium Additive / SF99 Fee...
2021-04-08
Written Confirmation

Close WC

Application Number
303MF40016
Status
 
Filing Details
Medium / Medium Additive / SF99 Fee...
Issue/Submission Date
2021-04-08
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Medium / Medium Additive / SF71 Feed Medium

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

303MF40017
Medium / Medium Additive / SF71 Fee...
2021-04-08
Written Confirmation

Close WC

Application Number
303MF40017
Status
 
Filing Details
Medium / Medium Additive / SF71 Fee...
Issue/Submission Date
2021-04-08
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Medium / Medium Additive / SF77 Feed Medium

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USDMF

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CEP/COS

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Japanese DMF

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303MF40018
Medium / Medium Additive / SF77 Fee...
2021-04-08
Written Confirmation

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Application Number
303MF40018
Status
 
Filing Details
Medium / Medium Additive / SF77 Fee...
Issue/Submission Date
2021-04-08
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Medium / medium additive · NS0 cell line -NM18. LS1 me...

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USDMF

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CEP/COS

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227MF40003
Medium / medium additive · NS0 cel...
2015-02-09
Written Confirmation

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Application Number
227MF40003
Status
 
Filing Details
Medium / medium additive · NS0 cel...
Issue/Submission Date
2015-02-09
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Medium / medium additive · NS0 cell line -NM12. LS1 me...

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USDMF

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227MF40004
Medium / medium additive · NS0 cel...
2015-02-09
Written Confirmation

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Application Number
227MF40004
Status
 
Filing Details
Medium / medium additive · NS0 cel...
Issue/Submission Date
2015-02-09
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Medium / Medium Additive / SF33 Feed Medium

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USDMF

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303MF40047
Medium / Medium Additive / SF33 Fee...
2021-08-19
Written Confirmation

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Application Number
303MF40047
Status
 
Filing Details
Medium / Medium Additive / SF33 Fee...
Issue/Submission Date
2021-08-19
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MAAA-1162a

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USDMF

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305MF10036
MAAA-1162a at Muenchensteiner stras...
2023-03-23
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Application Number
305MF10036
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MAAA-1162a at Muenchensteiner stras...
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2023-03-23
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Medium / medium additives · CM72 and CM73 medium

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USDMF

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228MF40014
Medium / medium additives · CM72 a...
2016-06-06
Written Confirmation

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Application Number
228MF40014
Status
 
Filing Details
Medium / medium additives · CM72 a...
Issue/Submission Date
2016-06-06
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