01 1Taro Pharmaceutical Industries
02 2BASF
03 2Bayer AG
04 1Flamma SpA
05 1Glenmark Life Sciences
06 1Zhejiang Huahai Pharmaceutical
01 4AZELAIC ACID
02 1AZELAIC ACID (A)
03 1AZELAIC ACID, MICRONIZED
04 1DERMAZ 88 (AZELAIC ACID)
05 1DERMAZ 99 (AZELAIC ACID)
01 1China
02 4Germany
03 1India
04 1Italy
05 1U.S.A
01 8Active
01 4Complete
02 4Blank
GDUFA
DMF Review : Complete
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 : 11615
Submission : 1995-08-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-11-24
Pay. Date : 2014-11-11
DMF Number : 19481
Submission : 2006-05-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28190
Submission : 2014-06-26
Status : Active
Type : II
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 : 38042
Submission : 2023-02-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-15
Pay. Date : 2016-03-10
DMF Number : 29924
Submission : 2016-03-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-01-17
Pay. Date : 2019-09-30
DMF Number : 33485
Submission : 2019-09-17
Status : Active
Type : II
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