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FDA Approval

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FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
November 16, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Vasopressin(20 [USP'U] in 1 mL)

Products6

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

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Product Details

NDC Product Code
42023-190
Application Number
NDA204485
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
November 16, 2023
CHLOROBUTANOLInactive
Code: HM4YQM8WRCClass: IACTQuantity: 5 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 1.36 mg in 1 mL
Code: Y87Y826H08Class: ACTIBQuantity: 20 [USP'U] in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT

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Product Details

NDC Product Code
42023-237
Application Number
NDA204485
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
November 16, 2023
Code: Y87Y826H08Class: ACTIBQuantity: 0.2 [USP'U] in 1 mL
DEXTROSEInactive
Code: IY9XDZ35W2Class: IACT
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 0.0546 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 0.012 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT

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Product Details

NDC Product Code
42023-219
Application Number
NDA204485
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
November 16, 2023
DEXTROSEInactive
Code: IY9XDZ35W2Class: IACT
Code: Y87Y826H08Class: ACTIBQuantity: 0.4 [USP'U] in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 0.0546 mg in 1 mL
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 0.012 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT

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Product Details

NDC Product Code
42023-220
Application Number
NDA204485
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
November 16, 2023
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: Y87Y826H08Class: ACTIBQuantity: 0.6 [USP'U] in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 0.0546 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
DEXTROSEInactive
Code: IY9XDZ35W2Class: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 0.012 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT

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Product Details

NDC Product Code
42023-164
Application Number
NDA204485
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
November 16, 2023
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: Y87Y826H08Class: ACTIBQuantity: 20 [USP'U] in 1 mL
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 1.36 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT

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Product Details

NDC Product Code
42023-268
Application Number
NDA204485
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
November 16, 2023
WATERInactive
Code: 059QF0KO0RClass: IACT
DEXTROSEInactive
Code: IY9XDZ35W2Class: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 0.012 mg in 1 mL
Code: Y87Y826H08Class: ACTIBQuantity: 1 [USP'U] in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 0.0546 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
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