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FDA Approval

Dexamethasone Sodium Phosphate

CompanyMylan Institutional LLC (DUNS: 790384502)

Effective Date

November 4, 2019

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Dexamethasone(4 mg in 1 mL)

Products (4)

Dexamethasone Sodium Phosphate

NDC Product Code

67457-418

Application Number

ANDA040803

Marketing Category

ANDA (C73584)

Route of Administration

INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE

Effective Date

November 4, 2019

Ingredients

DexamethasoneActive

Code: AI9376Y64PClass: ACTIRQuantity: 4 mg in 1 mL

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACTQuantity: 0.11 mg in 1 mL

METHYLPARABENInactive

Code: A2I8C7HI9TClass: IACTQuantity: 1.5 mg in 1 mL

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

PROPYLPARABENInactive

Code: Z8IX2SC1OHClass: IACTQuantity: 0.2 mg in 1 mL

ANHYDROUS TRISODIUM CITRATEInactive

Code: RS7A450LGAClass: IACTQuantity: 10 mg in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

Dexamethasone Sodium Phosphate

NDC Product Code

67457-419

Application Number

ANDA040803

Marketing Category

ANDA (C73584)

Route of Administration

INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE

Effective Date

November 4, 2019

Ingredients

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

DexamethasoneActive

Code: AI9376Y64PClass: ACTIRQuantity: 4 mg in 1 mL

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACTQuantity: 0.11 mg in 1 mL

METHYLPARABENInactive

Code: A2I8C7HI9TClass: IACTQuantity: 1.5 mg in 1 mL

PROPYLPARABENInactive

Code: Z8IX2SC1OHClass: IACTQuantity: 0.2 mg in 1 mL

ANHYDROUS TRISODIUM CITRATEInactive

Code: RS7A450LGAClass: IACTQuantity: 10 mg in 1 mL

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Dexamethasone Sodium Phosphate

NDC Product Code

67457-483

Application Number

ANDA040802

Marketing Category

ANDA (C73584)

Route of Administration

INTRAMUSCULAR, INTRAVENOUS

Effective Date

November 4, 2019

Ingredients

PROPYLPARABENInactive

Code: Z8IX2SC1OHClass: IACTQuantity: 0.2 mg in 1 mL

DexamethasoneActive

Code: AI9376Y64PClass: ACTIRQuantity: 10 mg in 1 mL

METHYLPARABENInactive

Code: A2I8C7HI9TClass: IACTQuantity: 1.5 mg in 1 mL

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACTQuantity: 0.11 mg in 1 mL

ANHYDROUS TRISODIUM CITRATEInactive

Code: RS7A450LGAClass: IACTQuantity: 10 mg in 1 mL

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

Dexamethasone Sodium Phosphate

NDC Product Code

67457-484

Application Number

ANDA040803

Marketing Category

ANDA (C73584)

Route of Administration

INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE

Effective Date

November 4, 2019

Ingredients

WATERInactive

Code: 059QF0KO0RClass: IACT

DexamethasoneActive

Code: AI9376Y64PClass: ACTIRQuantity: 4 mg in 1 mL

METHYLPARABENInactive

Code: A2I8C7HI9TClass: IACTQuantity: 1.5 mg in 1 mL

PROPYLPARABENInactive

Code: Z8IX2SC1OHClass: IACTQuantity: 0.2 mg in 1 mL

ANHYDROUS TRISODIUM CITRATEInactive

Code: RS7A450LGAClass: IACTQuantity: 10 mg in 1 mL

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACTQuantity: 0.11 mg in 1 mL

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

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