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Isoproterenol Hydrochloride

These highlights do not include all the information needed to use Isoproterenol hydrochloride safely and effectively. See full prescribing information for Isoproterenol hydrochloride. Isoproterenol hydrochloride injection, for intravenous use Initial U.S. Approval: 1956

Approved
Approval ID

dfb97590-dcbf-47e7-bbfe-f01580eb6ed0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 31, 2023

Manufacturers
FDA

Nexus Pharmaceuticals Inc

DUNS: 620714787

Products 2

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

Isoproterenol Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code14789-011
Application NumberANDA206961
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isoproterenol Hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMarch 31, 2023
FDA Product Classification

INGREDIENTS (6)

Isoproterenol HydrochlorideActive
Quantity: 0.2 mg in 1 mL
Code: DIA2A74855
Classification: ACTIB
EDETIC ACIDInactive
Code: 9G34HU7RV0
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT

Isoproterenol Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code14789-015
Application NumberANDA206961
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isoproterenol Hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMarch 31, 2023
FDA Product Classification

INGREDIENTS (6)

Isoproterenol HydrochlorideActive
Quantity: 0.2 mg in 1 mL
Code: DIA2A74855
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
EDETIC ACIDInactive
Code: 9G34HU7RV0
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT

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Isoproterenol Hydrochloride - FDA Drug Approval Details