01 1Kyowa Pharma Chemical Co Ltd
02 1ORGAMOL PHARMA SOLUTIONS SA
03 1Recipharm AB
04 1Shanghai Wonder Pharmaceutical
05 1Siegfried AG
06 1Wuhan Wuyao Pharmaceutical
07 1Blank
01 2China
02 1Japan
03 1Sweden
04 2Switzerland
05 1Blank
01 3Active
02 3Inactive
03 1Blank
01 7Blank
01 1222MF10113
02 6Blank
01 7Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39268
Submission : 2023-12-19
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-06-28
Pay. Date : 2021-03-11
DMF Number : 35698
Submission : 2021-04-21
Status : Active
Type : II
NDC Package Code : 66583-0810
Start Marketing Date : 2021-04-05
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-05-24
Pay. Date : 2015-07-27
DMF Number : 8002
Submission : 1989-03-23
Status : Active
Type : II
NDC Package Code : 17381-090
Start Marketing Date : 2010-05-11
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3670
Submission : 1979-12-28
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4282
Submission : 1981-09-10
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23147
Submission : 2009-09-29
Status : Inactive
Type : II
Registration Number : 222MF10113
Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture
Initial Date of Registration : 2010-03-23
Latest Date of Registration : --
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