01 1Apotex Pharmachem
02 1Beijing Huikang Boyuan Chemical Tech CO.
03 2CTX Lifesciences
04 1Cipla
05 1Fuxin Long Rui Pharmaceutical
06 1Guangzhou Tosun Pharmaceutical
07 1Hetero Drugs
08 2MSN Laboratories
09 2Morepen Laboratories
10 1Raks Pharma
11 1Teva API
12 1Teva Pharmaceutical Industries
13 1Viatris
14 1Wockhardt
01 1Canada
02 3China
03 10India
04 2Israel
05 1U.S.A
01 9Active
02 3Inactive
03 5Blank
01 17Blank
01 17Blank
01 1WC-0022
02 1WC-0022A3
03 1WC-0050
04 1WC-0050A4
05 1WC-0097
06 1WC-0097A3
07 1WC-0113
08 1WC-0157
09 9Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33635
Submission : 2019-02-27
Status : Active
Type : II
Date of Issue : 2019-06-17
Valid Till : 2022-06-16
Written Confirmation Number : WC-0050
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35690
Submission : 2021-02-27
Status : Active
Type : II
Date of Issue : 2021-12-24
Valid Till : 2022-06-16
Written Confirmation Number : WC-0050A4
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-08-19
Pay. Date : 2013-06-04
DMF Number : 27146
Submission : 2013-06-26
Status : Active
Type : II
Date of Issue : 2019-10-11
Valid Till : 2022-07-02
Written Confirmation Number : WC-0157
Address of the Firm :
NDC Package Code : 65015-830
Start Marketing Date : 2015-02-20
End Marketing Date : 2026-12-01
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-04-02
Pay. Date : 2020-11-02
DMF Number : 34165
Submission : 2020-11-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33486
Submission : 2019-07-05
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-08-19
Pay. Date : 2013-05-09
DMF Number : 27083
Submission : 2013-07-17
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-08-21
Pay. Date : 2013-06-10
DMF Number : 27189
Submission : 2013-06-14
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-08-19
Pay. Date : 2013-07-11
DMF Number : 27239
Submission : 2013-06-29
Status : Active
Type : II
Date of Issue : 2019-08-16
Valid Till : 2025-08-15
Written Confirmation Number : WC-0022
Address of the Firm :
NDC Package Code : 50370-0039
Start Marketing Date : 2013-06-29
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 : 29299
Submission : 2015-05-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27268
Submission : 2013-07-02
Status : Inactive
Type : II
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