01 1Avesta Pharma
02 7NOF CORPORATION
03 1Sumitomo Seika Chemicals
04 1The Dow Chemical Company
01 1India
02 8Japan
03 1U.S.A
01 8Active
02 2Blank
01 10Blank
01 1218MF20001
02 9Blank
01 10Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21153
Submission : 2007-12-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22570
Submission : 2009-02-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27603
Submission : 2013-10-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28678
Submission : 2014-09-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29335
Submission : 2015-04-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29524
Submission : 2015-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35636
Submission : 2021-03-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35552
Submission : 2021-03-09
Status : Active
Type : IV
NDC Package Code : 57449-011
Start Marketing Date : 2023-05-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registration Number : 218MF20001
Registrant's Address : 2211 H. H. Dow Way, Midland MI 48674, United States
Initial Date of Registration : 2006-02-23
Latest Date of Registration : --
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