01 1Bayer AG
02 1Bristol Myers Squibb
03 1Calyx Chemicals & Pharmaceuticals Limited
04 1SIGMA TAU
05 1Yangzhou Pharmaceutical
06 1Yuki Gosei Kogyo
07 1Blank
01 2ISONIAZID
02 1ISONIAZID (NEOTEBEN)
03 1ISONIAZID BULK FORM
04 1ISONIAZID USP23
05 1ISONICOTINIC ACID HYDRAZIDE
06 1NYDRAZID
01 1China
02 1Germany
03 1India
04 1Japan
05 2U.S.A
06 1Blank
01 3Active
02 4Inactive
01 2Complete
02 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5890
Submission : 1985-06-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 89
Submission : 1979-04-04
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-14
Pay. Date : 2015-09-30
DMF Number : 21322
Submission : 2008-02-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7689
Submission : 1988-09-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16235
Submission : 2002-11-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-06-17
Pay. Date : 2014-06-04
DMF Number : 4772
Submission : 1982-12-07
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14662
Submission : 2000-01-10
Status : Inactive
Type : II
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