01 1Aarti Drugs
02 1Amoli Organics
03 1Arch Pharmalabs
04 1Cambrex Corporation
05 1Dipharma
06 1Syn-Tech Chem. & Pharm
07 1YUNG ZIP CHEMICAL INDUSTRIAL
08 1Zydus Lifesciences
01 4India
02 1Italy
03 2Taiwan
04 1U.S.A
01 4Active
02 2Inactive
03 2Blank
01 8Blank
01 8Blank
01 8Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23909
Submission : 2010-06-18
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-03-03
Pay. Date : 2014-04-30
DMF Number : 24962
Submission : 2011-05-05
Status : Active
Type : II
NDC Package Code : 54871-1093
Start Marketing Date : 2013-02-07
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 : 25224
Submission : 2011-09-16
Status : Active
Type : II
NDC Package Code : 62512-0046
Start Marketing Date : 2010-09-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26112
Submission : 2012-05-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25929
Submission : 2012-04-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24522
Submission : 2011-01-04
Status : Inactive
Type : II
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