01 1Apothecon Pharmaceuticals
02 1Biofer
03 1Cilag AG
04 1Emcure Pharmaceuticals
05 1Opocrin SpA
06 1Suven Life Sciences Limited
07 1Viatris
08 1Vijayasri Organics Limited
01 4India
02 2Italy
03 1Switzerland
04 1U.S.A
01 3Active
02 3Inactive
03 2Blank
01 8Blank
01 8Blank
01 1WC-0042
02 7Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34228
Submission : 2019-12-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17746
Submission : 2004-10-07
Status : Active
Type : II
NDC Package Code : 44498-001
Start Marketing Date : 2005-01-01
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 : 18541
Submission : 2005-07-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17645
Submission : 2004-08-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17602
Submission : 2004-08-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21983
Submission : 2008-09-17
Status : Inactive
Type : II
Date of Issue : 2019-07-15
Valid Till : 2022-07-14
Written Confirmation Number : WC-0042
Address of the Firm :
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