01 1ACS DOBFAR SPA
02 1Astellas Pharma
03 1DEAFARMA
04 1Grand Health Industrial Co Ltd
05 1Olon S.p.A
06 1Orchid Pharma
07 4Blank
01 1China
02 1India
03 3Italy
04 1Japan
05 4Blank
01 2Active
02 6Inactive
03 2Blank
01 10Blank
01 1219MF10322
02 9Blank
01 1WC-0131N
02 9Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15022
Submission : 2000-09-12
Status : Active
Type : II
Date of Issue : 2019-08-16
Valid Till : 2022-07-21
Written Confirmation Number : WC-0131N
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10731
Submission : 1993-11-01
Status : Active
Type : II
Registration Number : 219MF10322
Registrant's Address : Strada Rivoltana Km 6/7 20090 Rodano Milano Italy
Initial Date of Registration : 2007-10-24
Latest Date of Registration : --
NDC Package Code : 17337-0300
Start Marketing Date : 2010-04-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10156
Submission : 1991-10-08
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8137
Submission : 1989-07-12
Status : Inactive
Type : II
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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 8634
Submission : 1990-07-02
Status : Inactive
Type : II
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Website
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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 : 8635
Submission : 1990-07-02
Status : Inactive
Type : II
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Website
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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 10129
Submission : 1988-11-18
Status : Inactive
Type : II
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Website
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15144
Submission : 2000-11-20
Status : Inactive
Type : II
NDC Package Code : 52946-0832
Start Marketing Date : 2009-12-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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