01 2ACIC Europe API & Pharmaceuticals
02 1CTX Lifesciences
03 1Cambrex Corporation
04 1Chifeng Arker Pharmaceutical Technology Co. Ltd.
05 1GLAND PHARMA LIMITED
06 1Napp Technologies
07 1Pliva Hrvatska
08 1Reliable Biopharmaceutical Corporation
09 1Shanghai Ziyuan Pharmaceutical
10 1Sun Pharmaceutical Industries Limited
01 2China
02 1Croatia
03 2Cyprus
04 3India
05 3U.S.A
01 5Active
02 6Inactive
01 11Blank
01 11Blank
01 1WC-0097
02 10Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24084
Submission : 2010-08-14
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-10-05
Pay. Date : 2022-09-19
DMF Number : 37227
Submission : 2022-06-30
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-06-12
Pay. Date : 2020-06-09
DMF Number : 22730
Submission : 2009-05-07
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-04
Pay. Date : 2013-02-07
DMF Number : 23015
Submission : 2009-07-23
Status : Active
Type : II
Date of Issue : 2022-06-24
Valid Till : 2025-07-02
Written Confirmation Number : WC-0097
Address of the Firm :
NDC Package Code : 42419-007
Start Marketing Date : 2009-07-23
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22017
Submission : 2008-09-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4315
Submission : 1981-10-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2527
Submission : 1975-09-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4325
Submission : 1981-10-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21745
Submission : 2008-06-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4610
Submission : 1982-06-16
Status : Inactive
Type : II
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