01 1ALP Pharm
02 1Apotex Pharmachem
03 1Aspen Biopharma Labs
04 1Beijing Lunarsun Pharmaceutical Co., Ltd
05 1Cipla
06 1Guangzhou Tosun Pharmaceutical
07 1Hetero Drugs
08 1Jeil Pharmaceutical Co., Ltd
09 1Nanjing Bold Chemical
10 1Qilu Pharmaceutical
11 1RANBAXY LABORATORIES LIMITED
12 1Shouyuan Chemical
13 1Sigmapharm Laboratories, LLC
14 1Viatris
01 1Canada
02 6China
03 4India
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05 2U.S.A
01 2Active
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01 1WC-0066
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
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 :
Pay. Date :
DMF Number : 24336
Submission : 2010-10-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
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 :
Pay. Date :
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
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
Date of Issue : 2019-08-09
Valid Till : 2025-08-08
Written Confirmation Number : WC-0066
Address of the Firm :
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