01 1Chongqing Huapont Pharmaceutical
02 1Guangzhou Tosun Pharmaceutical
03 1Luohe Chief Pharmaceutical
04 2Lupin Ltd
05 1Olon S.p.A
06 1Pfizer Inc
01 3China
02 2India
03 1Italy
04 1U.S.A
01 3Active
02 4Blank
01 1Expired
02 6Blank
01 7Blank
01 1WC-0049
02 1WC-0201
03 5Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2018-07-20
Pay. Date : 2018-05-08
DMF Number : 29047
Submission : 2015-01-22
Status : Active
Type : II
NDC Package Code : 17337-0059
Start Marketing Date : 2014-10-01
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 : 19902
Submission : 2006-10-20
Status : Active
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-09-10
Written Confirmation Number : WC-0201
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35705
Submission : 2024-02-06
Status : Active
Type : II
Date of Issue : 2022-06-07
Valid Till : 2025-06-16
Written Confirmation Number : WC-0049
Address of the Firm :
Certificate Number : R0-CEP 2001-111 - Rev 01
Issue Date : 2005-03-10
Type : TSE
Substance Number : 1657
Status : Expired
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