01 3Everlight Chemical
02 2Kyowa Pharma Chemical Co Ltd
03 1Pharmatech
04 1Piramal Pharma Solutions
05 2Teva API
06 2Yonsung Fine Chemicals
01 5MISOPROSTOL
02 1MISOPROSTOL - HPMC 1% DISPERSION
03 1MISOPROSTOL DISPERSION
04 1MISOPROSTOL DRUG SUBSTANCE
05 1MISOPROSTOL HPMC 1% DISPERSION
06 1MISOPROSTOL HPMC DISPERSION
07 1MISOPROSTOL HPMC DISPERSION 1:100
01 2Israel
02 2Japan
03 2South Korea
04 3Taiwan
05 1U.S.A
06 1United Kingdom
01 4Active
02 7Inactive
01 4Complete
02 7Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-31
Pay. Date : 2013-01-10
DMF Number : 17076
Submission : 2003-11-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-30
Pay. Date : 2013-01-10
DMF Number : 15017
Submission : 2000-08-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14500
Submission : 1999-10-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15068
Submission : 2000-09-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15044
Submission : 2000-09-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12729
Submission : 1997-11-07
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-07
Pay. Date : 2013-01-18
DMF Number : 21188
Submission : 2007-12-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14391
Submission : 1999-09-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14390
Submission : 1999-09-07
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-03
Pay. Date : 2013-09-25
DMF Number : 23042
Submission : 2009-08-14
Status : Active
Type : II
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