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List of Drug Master Files (DMF) of Ticagrelor Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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TICAGRELOR

TICAGRELOR (CAS: 274693-27-5)

TICAGRELOR (FORM-II) [ROUTE CODE "TG2"]

TICAGRELOR INTERMEDIATE, (1R, 2S) -2- (3,4-DIFLUOROPHENYL) CYCLOPROPANAMINE (R)-2-HYDROXY-2-PHENYLACETATE (1:1) (CAS: 376608-71-8)

TICAGRELOR INTERMEDIATE, 2-((3AR, 4S, 6R, 6AS)-6-AMINO-2, 2-DIMETHYLTETRAHYDRO-3AH-CYCLOPENTA [D] [1,3] DIOXOL-4-YLOXY) ETHANOL L-TARTARIC ACID (1:1) (CAS:376608-65-0)

TICAGRELOR INTERMEDIATE, 4, 6-DICHLORO-2-(PROPYLTHIO) PYRIMIDINE-5-AMINE (CAS: 145783-15-9)

TICAGRELOR NON-STERILE BULK DRUG SUBSTANCE

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28899
Active
2015-01-09
Complete
2015-02-17
2014-12-24
II

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28984
Active
2015-01-14
Complete
2015-06-29
2015-01-16
II

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28446
Active
2014-08-28
Complete
2014-10-27
2014-08-07
II

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28787
Active
2015-01-30
Complete
2015-05-26
2014-12-04
II

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28879
Active
2015-01-07
Complete
2015-03-13
2014-12-23
II

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28915
Active
2015-02-06
Complete
2015-06-05
2015-01-21
II

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29012
Active
2015-02-13
Complete
2015-05-21
2015-03-04
II

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28938
Active
2015-01-27
Complete
2015-04-03
2015-01-06
II

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28812
Active
2014-12-10
Complete
2015-02-25
2014-11-25
II

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29065
Active
2015-02-25
Complete
2015-04-28
2015-02-16
II

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31482
Active
2018-03-30
Complete
2019-06-03
2018-03-27
II

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28880
Active
2015-01-21
Complete
2015-03-17
2014-12-09
II

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28923
Active
2014-12-25
Complete
2015-02-13
2014-12-24
II

UNICHEM LABORATORIES LTD

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33563
Active
2019-03-26
Complete
2019-05-10
2019-01-14
II

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