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01 1APIXABAN
02 1BUDESONIDE MICRONIZED
03 1ESLICARBAZEPINE ACETATE
04 1ESMOLOL HYDROCHLORIDE
05 1ESOMEPRAZOLE MAGNESIUM DIHYDRATE MICRONIZED AND NON MICRONIZED
06 1ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
07 1FLUORESCEIN
08 1LAPATINIB DITOSYLATE
09 1METHAZOLAMIDE
10 1MIRABEGRON
11 1MONTELUKAST SODIUM THIOL ACID
12 1PENTAMIDINE ISETHIONATE
13 1PYRAZINAMIDE
14 1ROSUVASTATIN CALCIUM
15 1SOLIFENACIN SUCCINATE
16 1SORAFENIB HEMITOSYLATE
17 1SUCCINYLCHOLINE CHLORIDE
18 1TOFACITINIB CITRATE
19 1VINBLASTINE SULFATE
20 1VINCRISTINE SULFATE
21 1VINORELBINE TARTRATE
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01 15DELMAR CHEMICALS INC
02 3MINAKEM
03 3MINAKEM HIGH POTENT
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01 15Canada
02 6France
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01 21Active
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01 15Complete
02 6Blank
GDUFA
DMF Review : Complete
Rev. Date : 2016-08-15
Pay. Date : 2016-03-28
DMF Number : 30336
Submission : 2016-03-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-03
Pay. Date : 2017-02-10
DMF Number : 28441
Submission : 2014-06-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-07-27
Pay. Date : 2017-06-09
DMF Number : 31791
Submission : 2017-06-05
Status : Active
Type : II