01 3Actylis
02 1Ajinomoto Company
03 1Archimica
04 1Ash Stevens
05 1Biovectra Inc
06 1DALIAN ZHEN AO BIO TECH CO LTD
07 1Diagnostic Chemicals Limited CA C1E 2A6 Charlottetown
08 1Emcure Pharmaceuticals
09 1F. Hoffmann-La Roche
10 1Globofarm International
11 1Guangzhou Tosun Pharmaceutical
12 2Kyowa Hakko Bio
13 1Kyowa Pharma Chemical Co Ltd
14 1Reliable Biopharmaceutical Corporation
15 1Roche Diagnostics GmbH
16 2SIGMA TAU
17 1Shouyuan Chemical
18 1Tecoland Corporation
19 1Trifarma
20 1Wockhardt
21 1Zhejiang Hisun Pharmaceutical
22 1Blank
01 1Canada
02 4China
03 1Germany
04 3India
05 2Italy
06 4Japan
07 1Mexico
08 1Switzerland
09 8U.S.A
10 1Blank
01 6Active
02 14Inactive
03 6Blank
01 1Expired
02 3Valid
03 22Blank
01 26Blank
01 1WC-0075
02 25Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-21
Pay. Date : 2013-09-17
DMF Number : 22232
Submission : 2008-11-25
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-06-08
Pay. Date : 2013-05-30
DMF Number : 7728
Submission : 1988-10-25
Status : Active
Type : II
NDC Package Code : 12562-3021
Start Marketing Date : 1996-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 27732
Submission : 2014-02-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 23154
Submission : 2009-09-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8225
Submission : 1989-09-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8677
Submission : 1990-07-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 3412
Submission : 1978-12-20
Status : Inactive
Type : II
NDC Package Code : 12562-3021
Start Marketing Date : 1996-01-01
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 : 22824
Submission : 2009-05-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4208
Submission : 1981-07-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4842
Submission : 1983-03-07
Status : Inactive
Type : II
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