01 1DEAFARMA
02 1Gilead Sciences
03 1HONOUR LAB LTD
04 1Hangzhou Longshine Bio-Tech
05 1Hetero Drugs
06 1MSN Laboratories
07 1Mangalam Drugs & Organics Ltd
08 1Nanjing Clasien Pharmaceutical & Chemical Co., Ltd
09 1Sun-shine Chem
10 2Viatris
01 3China
02 4India
03 1Italy
04 3U.S.A
01 5Active
02 6Blank
01 11Blank
01 11Blank
01 1WC-0015
02 1WC-0383A4
03 9Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2018-03-16
Pay. Date : 2018-01-05
DMF Number : 30650
Submission : 2016-07-02
Status : Active
Type : II
Date of Issue : 2019-10-15
Valid Till : 2022-08-08
Written Confirmation Number : WC-0383A4
Address of the Firm :
NDC Package Code : 69766-011
Start Marketing Date : 2016-05-23
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-10-21
Pay. Date : 2016-08-16
DMF Number : 30287
Submission : 2016-09-07
Status : Active
Type : II
NDC Package Code : 69037-0025
Start Marketing Date : 2015-06-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-20
Pay. Date : 2014-07-28
DMF Number : 28438
Submission : 2014-08-08
Status : Active
Type : II
Date of Issue : 2019-06-03
Valid Till : 2022-06-02
Written Confirmation Number : WC-0015
Address of the Firm :
NDC Package Code : 65015-849
Start Marketing Date : 2015-03-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-10-14
Pay. Date : 2015-08-31
DMF Number : 29615
Submission : 2015-09-02
Status : Active
Type : II
NDC Package Code : 65015-849
Start Marketing Date : 2015-03-03
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 : 25188
Submission : 2011-10-24
Status : Active
Type : II
NDC Package Code : 54014-9350
Start Marketing Date : 2012-08-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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