01 1Taro Pharmaceutical Industries
02 1Azelaic Products
03 2BASF
04 2Bayer AG
05 1Flamma SpA
06 2Glenmark Life Sciences
07 1Glenmark Pharmaceuticals
08 1Guangzhou Tosun Pharmaceutical
09 1Nantong Jinghua Pharmaceutical
10 1Tyche Industries Ltd
11 1Zhejiang Huahai Pharmaceutical
01 3China
02 4Germany
03 4India
04 1Italy
05 1Netherlands
06 1U.S.A
01 8Active
02 6Blank
01 14Blank
01 14Blank
01 1WC-0057A4
02 1WC-0231
03 1WC-0310
04 11Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2016-02-05
Pay. Date : 2015-11-30
DMF Number : 29484
Submission : 2015-12-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38042
Submission : 2023-02-24
Status : Active
Type : II
NDC Package Code : 54236-050
Start Marketing Date : 2017-11-09
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 : 11615
Submission : 1995-08-04
Status : Active
Type : II
NDC Package Code : 48041-4700
Start Marketing Date : 2013-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-11-24
Pay. Date : 2014-11-11
DMF Number : 19481
Submission : 2006-05-31
Status : Active
Type : II
NDC Package Code : 48041-4700
Start Marketing Date : 2013-01-01
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 : 9289
Submission : 1991-08-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28190
Submission : 2014-06-26
Status : Active
Type : II
Date of Issue : 2022-06-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0231
Address of the Firm :
NDC Package Code : 60862-007
Start Marketing Date : 2018-12-18
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (0.1kg/.1kg)
Marketing Category : BULK INGREDIENT
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