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FDA Approval

Diatrizoate Meglumine and Diatrizoate Sodium

CompanyGuardian Drug Company (DUNS: 119210276)

Effective Date

October 22, 2020

Labeling Type

Human Prescription Drug Label

Active Ingredients

Diatrizoate(100 mg in 1 mL)

Diatrizoate meglumine/iodipamide meglumine(660 mg in 1 mL)

Manufacturing Establishments (1)

Guardian Drug Company

Labeler

Guardian Drug Company

DUNS Number

119210276

Products (2)

Diatrizoate Meglumine and Diatrizoate Sodium

NDC Product Code

53041-688

Application Number

ANDA214201

Marketing Category

ANDA (C73584)

Route of Administration

ORAL, RECTAL

Effective Date

December 18, 2020

Ingredients

DiatrizoateActive

Code: V5403H8VG7Class: ACTIBQuantity: 100 mg in 1 mL

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SACCHARIN SODIUMInactive

Code: SB8ZUX40TYClass: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1OClass: IACT

SODIUM CITRATE, UNSPECIFIED FORMInactive

Code: 1Q73Q2JULRClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

Diatrizoate meglumine/iodipamide meglumineActive

Code: 3X9MR4N98UClass: ACTIBQuantity: 660 mg in 1 mL

Diatrizoate Meglumine and Diatrizoate Sodium

NDC Product Code

53041-690

Application Number

ANDA214201

Marketing Category

ANDA (C73584)

Route of Administration

ORAL, RECTAL

Effective Date

December 18, 2020

Ingredients

DIMETHICONEInactive

Code: 92RU3N3Y1OClass: IACT

DiatrizoateActive

Code: V5403H8VG7Class: ACTIBQuantity: 100 mg in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

SACCHARIN SODIUMInactive

Code: SB8ZUX40TYClass: IACT

SODIUM CITRATE, UNSPECIFIED FORMInactive

Code: 1Q73Q2JULRClass: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

Diatrizoate meglumine/iodipamide meglumineActive

Code: 3X9MR4N98UClass: ACTIBQuantity: 660 mg in 1 mL

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