01 2ACS DOBFAR SPA
02 1Akums Lifesciences
03 1Alembic Pharmaceuticals Limited
04 2Aurobindo Pharma Limited
05 1Bristol Myers Squibb
06 2CSPC Pharmaceutical Group
07 4GSK
08 1Harbin Pharmaceutical Group Co., Ltd.
09 1Inner Mongolia Changsheng Pharmaceutical
10 1NCPC HUALUAN PHARMACEUTICAL CO LTD
11 1Oman Chemicals & Pharmaceuticals LLC
12 1Quimica Sintetica
13 1Sandoz B2B
14 1Sichuan Kelun Pharmaceutical
15 1Sinopharm Weiqida Pharmaceutical Co Ltd
16 1The United Laboratories
17 1Torrent Pharmaceuticals Limited
18 1UNITED LABORATORIES CHENGDU CO LTD
19 2Blank
01 7China
02 2Hong Kong
03 5India
04 2Italy
05 1Oman
06 1Spain
07 1Switzerland
08 1U.S.A
09 4United Kingdom
10 2Blank
01 8Active
02 18Inactive
01 26Blank
01 26Blank
01 26Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21994
Submission : 2008-09-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27248
Submission : 2013-06-04
Status : Active
Type : II
NDC Package Code : 52115-000
Start Marketing Date : 2013-06-24
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 : 30779
Submission : 2016-08-02
Status : Active
Type : II
NDC Package Code : 55657-100
Start Marketing Date : 2005-03-31
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 : 19525
Submission : 2006-06-19
Status : Active
Type : II
NDC Package Code : 32903-045
Start Marketing Date : 2005-03-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32467
Submission : 2017-12-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17197
Submission : 2004-02-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22393
Submission : 2008-12-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17694
Submission : 2004-09-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21932
Submission : 2008-08-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10139
Submission : 1968-06-10
Status : Inactive
Type : II
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