01 1Corden Pharma Bergamo S.p.A
02 1DOTTIKON EXCLUSIVE SYNTHESIS AG
03 2Emcure Pharmaceuticals
04 1Hengdian Group
05 1Pfizer Inc
06 1Viatris
01 1China
02 2India
03 1Italy
04 1Switzerland
05 2U.S.A
01 3Active
02 3Inactive
03 1Blank
01 7Blank
01 7Blank
01 1WC-0226
02 6Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27618
Submission : 2013-12-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 17677
Submission : 2004-09-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 39269
Submission : 2023-12-20
Status : Active
Type : II
NDC Package Code : 65015-901
Start Marketing Date : 2024-03-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
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DMF Number : 6443
Submission : 1986-06-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21981
Submission : 2008-09-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21633
Submission : 2008-05-19
Status : Inactive
Type : II
Date of Issue : 2019-10-07
Valid Till : 2022-07-02
Written Confirmation Number : WC-0226
Address of the Firm :
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