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01 1Jai Radhe Sales
02 1Anugraha Chemicals
03 1Asia Pioneer Pharmaceuticals
04 2Kawaken Fine Chemicals
05 1Natco Pharma
06 1ORGANICA Feinchemie GmbH Wolfen
07 2Olon S.p.A
08 1R L Fine Chem
09 1Trifarma
01 1Germany
02 4India
03 3Italy
04 2Japan
05 1U.S.A
01 2Active
02 2Inactive
03 7Blank
01 11Blank
01 1218MF10866
02 1219MF10362
03 1227MF10190
04 1230MF10094
05 7Blank
01 1WC-0014
02 10Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2693
Submission : 1976-06-16
Status : Active
Type : II
Registration Number : 219MF10362
Registrant's Address : Strada Rivoltana, km 6/7, 20053 Rodano (MI), Italy
Initial Date of Registration : 2007-12-13
Latest Date of Registration : --
NDC Package Code : 17337-0038
Start Marketing Date : 2012-12-27
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 : 22576
Submission : 2009-02-26
Status : Active
Type : II
Date of Issue : 2019-06-26
Valid Till : 2022-06-25
Written Confirmation Number : WC-0014
Address of the Firm :
NDC Package Code : 63850-6535
Start Marketing Date : 2016-01-21
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 : 5802
Submission : 1985-02-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2785
Submission : 1976-11-05
Status : Inactive
Type : II
NDC Package Code : 71554-022
Start Marketing Date : 2020-10-23
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registration Number : 230MF10094
Registrant's Address : 2-3-3 Nihonbashi Horidomecho, Chuo-ku, Tokyo
Initial Date of Registration : 2018-07-26
Latest Date of Registration : --
Registration Number : 227MF10190
Registrant's Address : Strada Rivoltana, km 6/7, 20053 Rodano (MI), Italy
Initial Date of Registration : 2015-08-03
Latest Date of Registration : --
NDC Package Code : 17337-0038
Start Marketing Date : 2012-12-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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