Please Wait
Applying Filters...

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

Filters
×

filter

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

filter

CHINA

INDIA

ISRAEL

POLAND

SLOVENIA

UNITED STATES

Blank

filter

Active

Inactive

filter

Complete

Blank

European generic drug manufacturer/ API Supplier/ 6 manufacturing sites/ 5 R&D Centers/ 700 products & 250 under develop...

DMF Number

28674

Status

Active

Submission Date

2014-09-24

GDUFA DMF Review

Complete

GDUFA Review Date

2015-02-23

GDUFA Payment Date

2014-11-21

Type

II

Supporting Information

View All

Polpharma-Company-Banner

CPhI Middle East & Africa

Request an Update of Your Company Information, Events & Sales Content

DMF Number

28899

Status

Active

Submission Date

2015-01-09

GDUFA DMF Review

Complete

GDUFA Review Date

2015-02-17

GDUFA Payment Date

2014-12-24

Type

II

Supporting Information

Request an Update of Your Company Information, Events & Sales Content

DMF Number

28984

Status

Active

Submission Date

2015-01-14

GDUFA DMF Review

Complete

GDUFA Review Date

2015-06-29

GDUFA Payment Date

2015-01-16

Type

II

Supporting Information

View All

Request an Update of Your Company Information, Events & Sales Content

DMF Number

28446

Status

Active

Submission Date

2014-08-28

GDUFA DMF Review

Complete

GDUFA Review Date

2014-10-27

GDUFA Payment Date

2014-08-07

Type

II

Supporting Information

Request an Update of Your Company Information, Events & Sales Content

DMF Number

28787

Status

Active

Submission Date

2015-01-30

GDUFA DMF Review

Complete

GDUFA Review Date

2015-05-26

GDUFA Payment Date

2014-12-04

Type

II

Supporting Information

Request an Update of Your Company Information, Events & Sales Content

DMF Number

28879

Status

Active

Submission Date

2015-01-07

GDUFA DMF Review

Complete

GDUFA Review Date

2015-03-13

GDUFA Payment Date

2014-12-23

Type

II

Supporting Information

Request an Update of Your Company Information, Events & Sales Content

DMF Number

31620

Status

Active

Submission Date

2017-03-24

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

Request an Update of Your Company Information, Events & Sales Content

DMF Number

32399

Status

Active

Submission Date

2018-03-30

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

View All

Request an Update of Your Company Information, Events & Sales Content

DMF Number

28110

Status

Active

Submission Date

2014-02-20

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

Request an Update of Your Company Information, Events & Sales Content

DMF Number

28111

Status

Active

Submission Date

2014-02-20

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

Request an Update of Your Company Information, Events & Sales Content

DMF Number

28112

Status

Active

Submission Date

2014-02-20

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

Request an Update of Your Company Information, Events & Sales Content

DMF Number

28456

Status

Inactive

Submission Date

2014-07-01

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

Request an Update of Your Company Information, Events & Sales Content

DMF Number

28915

Status

Active

Submission Date

2015-02-06

GDUFA DMF Review

Complete

GDUFA Review Date

2015-06-05

GDUFA Payment Date

2015-01-21

Type

II

Supporting Information

Request an Update of Your Company Information, Events & Sales Content

DMF Number

29012

Status

Active

Submission Date

2015-02-13

GDUFA DMF Review

Complete

GDUFA Review Date

2015-05-21

GDUFA Payment Date

2015-03-04

Type

II

Supporting Information

Request an Update of Your Company Information, Events & Sales Content

DMF Number

28938

Status

Active

Submission Date

2015-01-27

GDUFA DMF Review

Complete

GDUFA Review Date

2015-04-03

GDUFA Payment Date

2015-01-06

Type

II

Supporting Information

Request an Update of Your Company Information, Events & Sales Content

DMF Number

28812

Status

Active

Submission Date

2014-12-10

GDUFA DMF Review

Complete

GDUFA Review Date

2015-02-25

GDUFA Payment Date

2014-11-25

Type

II

Supporting Information

Request an Update of Your Company Information, Events & Sales Content

DMF Number

29065

Status

Active

Submission Date

2015-02-25

GDUFA DMF Review

Complete

GDUFA Review Date

2015-04-28

GDUFA Payment Date

2015-02-16

Type

II

Supporting Information

Request an Update of Your Company Information, Events & Sales Content

DMF Number

31482

Status

Active

Submission Date

2018-03-30

GDUFA DMF Review

Complete

GDUFA Review Date

2019-06-03

GDUFA Payment Date

2018-03-27

Type

II

Supporting Information

Request an Update of Your Company Information, Events & Sales Content

DMF Number

28880

Status

Active

Submission Date

2015-01-21

GDUFA DMF Review

Complete

GDUFA Review Date

2015-03-17

GDUFA Payment Date

2014-12-09

Type

II

Supporting Information

View All

Request an Update of Your Company Information, Events & Sales Content

DMF Number

29568

Status

Active

Submission Date

2015-07-17

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

Request an Update of Your Company Information, Events & Sales Content

DMF Number

28923

Status

Active

Submission Date

2014-12-25

GDUFA DMF Review

Complete

GDUFA Review Date

2015-02-13

GDUFA Payment Date

2014-12-24

Type

II

Supporting Information

UNICHEM LABORATORIES LTD

Request an Update of Your Company Information, Events & Sales Content

DMF Number

33563

Status

Active

Submission Date

2019-03-26

GDUFA DMF Review

Complete

GDUFA Review Date

2019-05-10

GDUFA Payment Date

2019-01-14

Type

II

Supporting Information

PharmaCompass >>

First
Previous
Next
Last