01 1Alembic Pharmaceuticals Limited
02 1Hetero Drugs
03 1MSN Laboratories
04 1ScinoPharm Taiwan, Ltd
01 4OSIMERTINIB MESYLATE
01 3India
02 1Taiwan
01 4Active
01 2Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-26
Pay. Date : 2018-12-12
DMF Number : 33409
Submission : 2018-12-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35581
Submission : 2021-02-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-05-06
Pay. Date : 2019-03-14
DMF Number : 32143
Submission : 2017-12-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36546
Submission : 2021-12-24
Status : Active
Type : II
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