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FDA Approval

MD GASTROVIEW

CompanyLiebel-Flarsheim Company LLC (DUNS: 057880002)

Effective Date

January 1, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Diatrizoate(100 mg in 1 mL)

Diatrizoate meglumine/iodipamide meglumine(600 mg in 1 mL)

Manufacturing Establishments (2)

Justesa Imagen, S.A.U.

Labeler

Liebel-Flarsheim Company LLC

DUNS Number

477020325

LIEBEL-FLARSHEIM COMPANY LLC

Labeler

Liebel-Flarsheim Company LLC

DUNS Number

109024984

Products (1)

MD GASTROVIEW

NDC Product Code

0019-4816

Application Number

ANDA087388

Marketing Category

ANDA (C73584)

Route of Administration

ORAL, RECTAL

Effective Date

February 15, 2017

Ingredients

SODIUM CITRATEInactive

Code: 1Q73Q2JULRClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

DiatrizoateActive

Code: V5403H8VG7Class: ACTIBQuantity: 100 mg in 1 mL

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

SACCHARIN SODIUMInactive

Code: SB8ZUX40TYClass: IACT

Diatrizoate meglumine/iodipamide meglumineActive

Code: 3X9MR4N98UClass: ACTIBQuantity: 600 mg in 1 mL

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