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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Leo Pharma

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Leo Pharma
Denmark Flag
Country
Country
Denmark
Address
Address
Industriparken 55
Telephone
Telephone
+45 4494 5888
Linkedin
Linkedin
Twitter
Twitter

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USDMF

Caution USDMF

8308
Inactive
CALCIPOTRIENE DRUG SUBSTANCE
1989-11-01
CEP/COS

Found CEP/COS

R1-CEP 2005-148 - Rev 01
Valid
Calcipotriol
2013-03-13
Japanese DMF

Found JDMF

219MF10045
Calcipotriol at Industriparken 55, ...
2007-02-13
Written Confirmation

Close WC

Application Number
8308
219MF10045
Status
Inactive
Fees Unpaid
N/A
Valid
 
Filing Details
CALCIPOTRIENE DRUG SUBSTANCE
Calcipotriol
Calcipotriol at Industriparken 55, ...
Issue/Submission Date
1989-11-01
2013-03-13
2007-02-13
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USDMF

Caution USDMF

8527
Inactive
SODIUM FUSIDATE
1990-04-16
CEP/COS

Found CEP/COS

R0-CEP 2021-041 - Rev 01
Valid
Sodium fusidate Micronised, Process...
2022-01-19
Japanese DMF

Found JDMF

218MF10952
Fusidic acid sodium at Industripark...
2006-11-24
Written Confirmation

Close WC

Application Number
8527
218MF10952
Status
Inactive
Fees Unpaid
N/A
Valid
 
Filing Details
SODIUM FUSIDATE
Sodium fusidate Micronised, Process...
Fusidic acid sodium at Industripark...
Issue/Submission Date
1990-04-16
2022-01-19
2006-11-24
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USDMF

Caution USDMF

8312
Inactive
CALCIPOTRIENE OINTMENT
1989-11-27
CEP/COS

Found CEP/COS

R1-CEP 2005-145 - Rev 01
Valid
Calcipotriol monohydrate
2013-04-09
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
8312
Status
Inactive
Fees Unpaid
N/A
Valid
 
Filing Details
CALCIPOTRIENE OINTMENT
Calcipotriol monohydrate
Issue/Submission Date
1989-11-27
2013-04-09
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USDMF

Caution USDMF

8526
Inactive
FUSIDIC ACID
1990-04-16
CEP/COS

Found CEP/COS

R0-CEP 2021-040 - Rev 01
Valid
Fusidic acid Micronised, Process II
2022-01-19
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
8526
Status
Inactive
Fees Unpaid
N/A
Valid
 
Filing Details
FUSIDIC ACID
Fusidic acid Micronised, Process II
Issue/Submission Date
1990-04-16
2022-01-19
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USDMF

Caution USDMF

8528
Inactive
FUCIDIN CREAM
1990-04-16
CEP/COS

Found CEP/COS

R1-CEP 2009-308 - Rev 02
Valid
Fusidic acid Micronised
2022-01-19
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
8528
Status
Inactive
Fees Unpaid
N/A
Valid
 
Filing Details
FUCIDIN CREAM
Fusidic acid Micronised
Issue/Submission Date
1990-04-16
2022-01-19
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USDMF

Caution USDMF

8529
Inactive
FUCIDIN OINTMENT
1990-04-16
CEP/COS

Found CEP/COS

R1-CEP 2009-379 - Rev 00
Valid
Fusidic acid Micronised, sterile
2016-10-21
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
8529
Status
Inactive
Fees Unpaid
N/A
Valid
 
Filing Details
FUCIDIN OINTMENT
Fusidic acid Micronised, sterile
Issue/Submission Date
1990-04-16
2016-10-21
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USDMF

Caution USDMF

10477
Inactive
WEXPORT LTD. FACILITIES IN LITTLE I...
1993-09-03
CEP/COS

Found CEP/COS

R1-CEP 2001-446 - Rev 03
Valid
Heparin sodium For parenteral prepa...
2020-02-21
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
10477
Status
Inactive
Fees Unpaid
N/A
Valid
 
Filing Details
WEXPORT LTD. FACILITIES IN LITTLE I...
Heparin sodium For parenteral prepa...
Issue/Submission Date
1993-09-03
2020-02-21
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2007-286 - Rev 02
Valid
Alfacalcidol
2020-02-18
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
Status
Valid
 
Filing Details
Alfacalcidol
Issue/Submission Date
2020-02-18
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USDMF

Found USDMF

10514
Active
CALCIPOTRIENE HYDRATE DRUG SUBSTANC...
1993-10-08
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
10514
Status
Active
Fees Unpaid
N/A
 
Filing Details
CALCIPOTRIENE HYDRATE DRUG SUBSTANC...
Issue/Submission Date
1993-10-08
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USDMF

Found USDMF

10515
Active
CALCIPOTRIENE CREAM
1993-10-08
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
10515
Status
Active
Fees Unpaid
N/A
 
Filing Details
CALCIPOTRIENE CREAM
Issue/Submission Date
1993-10-08
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USDMF

Caution USDMF

10589
Inactive
HEPARIN SODIUM DRUG SUBSTANCE
1993-11-22
CEP/COS

Caution CEP/COS

R1-CEP 2001-445 - Rev 02
Withdrawn by Holder
Heparin sodium Potency not less tha...
2011-03-30
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
10589
Status
Inactive
Fees Unpaid
N/A
Withdrawn by Holder
 
Filing Details
HEPARIN SODIUM DRUG SUBSTANCE
Heparin sodium Potency not less tha...
Issue/Submission Date
1993-11-22
2011-03-30
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R0-CEP 2021-042 - Rev 00
Valid
Sodium fusidate Process II
2021-06-04
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
Status
Valid
 
Filing Details
Sodium fusidate Process II
Issue/Submission Date
2021-06-04
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2009-317 - Rev 02
Valid
Sodium fusidate Micronised
2022-01-19
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
Status
Valid
 
Filing Details
Sodium fusidate Micronised
Issue/Submission Date
2022-01-19
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2009-309 - Rev 00
Valid
Sodium fusidate
2016-07-29
Japanese DMF

Close JDMF