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01 2Calcipotriol
02 1Calcitriol
03 1Calcium Folinate
04 1Calcium Mefolinate
05 1Doxcercalciferol
06 1Leucovorin Sodium
07 1Levoleucovorin
08 1Levoleucovorin Calcium
09 1Levomefolate
10 1Levomefolate Calcium
11 2Tiotropium Bromide
12 1Urokinase
01 10Active
02 4Blank
01 2Valid
02 12Blank
01 1217MF11273
02 1221MF10021
03 12Blank
01 14Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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GDUFA
DMF Review : Reviewed
Rev. Date : 2015-03-05
Pay. Date : 2013-06-26
DMF Number : 23103
Submission : 2009-09-09
Status : Active
Type : II
Certificate Number : R1-CEP 2016-206 - Rev 01
Issue Date : 2022-11-30
Type : Chemical
Substance Number : 2284
Status : Valid
NDC Package Code : 54239-005
Start Marketing Date : 2009-09-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-22
Pay. Date : 2012-12-18
DMF Number : 14718
Submission : 2000-02-18
Status : Active
Type : II
Certificate Number : R1-CEP 2012-356 - Rev 00
Issue Date : 2019-02-20
Type : Chemical and TSE
Substance Number : 883
Status : Valid
NDC Package Code : 54239-004
Start Marketing Date : 2000-02-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Parmarine Co., Ltd.
Registration Date : 2021-03-18
Registration Number : 20210318-209-J-696
Manufacturer Name : Cerbios-Pharma
Manufacturer Address : 6900 Via Figino 6, CH-6917 Barbengo/Lugano, Switzerland
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-04
Pay. Date : 2013-09-25
DMF Number : 5046
Submission : 1983-06-30
Status : Active
Type : II
Registration Number : 221MF10021
Registrant's Address : Via Figino 6,6917 Barbengo/Lugano, Switzerland
Initial Date of Registration : 2009-01-28
Latest Date of Registration :
NDC Package Code : 54239-002
Start Marketing Date : 1983-06-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2022-01-05
Registration Number : 20220105-210-J-1193
Manufacturer Name : Cerbios pharma SA
Manufacturer Address : Via Figino 6, 6917 Barbengo/Lugano, Switzerland
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-09
Pay. Date : 2012-12-18
DMF Number : 23437
Submission : 2010-01-04
Status : Active
Type : II
Registration Number : 217MF11273
Registrant's Address : Via Figino 6,6917 Barbengo/Lugano, Switzerland
Initial Date of Registration : 2005-12-20
Latest Date of Registration :
NDC Package Code : 54239-007
Start Marketing Date : 2010-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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