Mikart, Inc | EU CTD Dossiers | In | Out | Licensing

As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

Country

Regulatory Info : DISCN

Registration Country : USA

ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE

Mikart

Dosage Form : CAPSULE;ORAL

Dosage Strength : 150MG;180MG;15MG

Packaging :

Approval Date : 1990-10-26

Application Number : 81095

Regulatory Info : DISCN

Registration Country : USA

02

Brand Name : ACETAMINOPHEN, ASPIR...

U.S.A

As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

Country

Regulatory Info : DISCN

Registration Country : USA

ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE

Mikart

Dosage Form : CAPSULE;ORAL

Dosage Strength : 150MG;180MG;30MG

Packaging :

Approval Date : 1990-10-26

Application Number : 81096

Regulatory Info : DISCN

Registration Country : USA

03

Brand Name : ACETAMINOPHEN, ASPIR...

U.S.A

As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

Country

Regulatory Info : DISCN

Registration Country : USA

ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE

Mikart

Dosage Form : CAPSULE;ORAL

Dosage Strength : 150MG;180MG;60MG

Packaging :

Approval Date : 1990-10-26

Application Number : 81097

Regulatory Info : DISCN

Registration Country : USA

04

Brand Name : BUTAPAP

U.S.A

As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

Country

Regulatory Info : DISCN

Registration Country : USA

ACETAMINOPHEN; BUTALBITAL

Mikart

Dosage Form : TABLET;ORAL

Dosage Strength : 650MG;50MG

Packaging :

Approval Date : 1992-10-26

Application Number : 89988

Regulatory Info : DISCN

Registration Country : USA

05

Brand Name : ESGIC-PLUS

U.S.A

As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

Country

Regulatory Info : DISCN

Registration Country : USA

Mikart

Dosage Form : CAPSULE;ORAL

Dosage Strength : 500MG;50MG;40MG

Packaging :

Approval Date : 1996-03-28

Application Number : 40085

Regulatory Info : DISCN

Registration Country : USA

06

Brand Name : BUTALBITAL, ACETAMIN...

U.S.A

As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

Country

Regulatory Info : RX

Registration Country : USA

Mikart

Dosage Form : SOLUTION;ORAL

Dosage Strength : 325MG/15ML;50MG/15ML;4...

Packaging :

Approval Date : 2003-01-31

Application Number : 40387

Regulatory Info : RX

Registration Country : USA

07

Brand Name : BUTALBITAL, ACETAMIN...

U.S.A

As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

Country

Regulatory Info : DISCN

Registration Country : USA

Mikart

Dosage Form : TABLET;ORAL

Dosage Strength : 750MG;50MG;40MG

Packaging :

Approval Date : 2003-12-23

Application Number : 40496

Regulatory Info : DISCN

Registration Country : USA

08

Brand Name : ESGIC-PLUS

U.S.A

As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

Country

Regulatory Info : DISCN

Registration Country : USA

Mikart

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG;50MG;40MG

Packaging :

Approval Date : 1988-05-23

Application Number : 89451

Regulatory Info : DISCN

Registration Country : USA

09

Brand Name : ACETAMINOPHEN, CAFFE...

U.S.A

As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

Country

Regulatory Info : DISCN

Registration Country : USA

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE

Mikart

Dosage Form : CAPSULE;ORAL

Dosage Strength : 356.4MG;30MG;16MG

Packaging :

Approval Date : 1997-08-26

Application Number : 40109

Regulatory Info : DISCN

Registration Country : USA

10

Brand Name : ACETAMINOPHEN, CAFFE...

U.S.A

As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

Country

Regulatory Info : DISCN

Registration Country : USA

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE

Mikart

Dosage Form : TABLET;ORAL

Dosage Strength : 712.8MG;60MG;32MG

Packaging :

Approval Date : 1999-04-28

Application Number : 40316

Regulatory Info : DISCN

Registration Country : USA