01 1ALP Pharm
02 1Apotex Pharmachem
03 1Aspen Biopharma Labs
04 1Beijing Lunarsun Pharmaceutical Co., Ltd
05 1Charioteer
06 1Cipla
07 1Guangzhou Tosun Pharmaceutical
08 1Hetero Drugs
09 1Jeil Pharmaceutical Co., Ltd
10 1Nanjing Bold Chemical
11 1Qilu Pharmaceutical
12 1RANBAXY LABORATORIES LIMITED
13 1Shouyuan Chemical
14 1Sigmapharm Laboratories, LLC
15 1Viatris
01 1Canada
02 7China
03 4India
04 1South Korea
05 2U.S.A
01 3Active
02 5Inactive
03 7Blank
01 15Blank
01 15Blank
01 1WC-0066
02 1WC-0157
03 13Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24151
Submission : 2010-08-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 23844
Submission : 2010-06-03
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-08-26
Pay. Date : 2012-12-06
DMF Number : 26630
Submission : 2012-12-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 24336
Submission : 2010-10-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 20192
Submission : 2007-03-27
Status : Inactive
Type : II
NDC Package Code : 53104-7602
Start Marketing Date : 2016-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 26117
Submission : 2012-05-30
Status : Inactive
Type : II
Date of Issue : 2019-10-11
Valid Till : 2022-07-02
Written Confirmation Number : WC-0157
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25641
Submission : 2011-12-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23993
Submission : 2010-07-26
Status : Inactive
Type : II
Date of Issue : 2019-08-09
Valid Till : 2025-08-08
Written Confirmation Number : WC-0066
Address of the Firm :
Registrant Name : Jeil Pharmaceutical Co., Ltd.
Registration Date : 2009-11-25
Registration Number : 21-4-ND
Manufacturer Name : Jeil Pharmaceutical Co., Ltd.
Manufacturer Address : 7_x000D_ Cheonggang Gachang-ro, Baekam-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do
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