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zinc sulfate

ZINC SULFATE INJECTION for intravenous use

Approved
Approval ID

74d8d07b-cfd9-4262-b689-fea12673bbd1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 31, 2023

Manufacturers
FDA

Zydus Lifesciences Limited

DUNS: 918596198

Products 3

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

zinc sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70771-1848
Application NumberANDA217074
Product Classification
M
Marketing Category
C73584
G
Generic Name
zinc sulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 31, 2023
FDA Product Classification

INGREDIENTS (3)

ZINC SULFATEActive
Quantity: 1 mg in 1 mL
Code: 89DS0H96TB
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT

zinc sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70771-1850
Application NumberANDA217074
Product Classification
M
Marketing Category
C73584
G
Generic Name
zinc sulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 31, 2023
FDA Product Classification

INGREDIENTS (3)

ZINC SULFATEActive
Quantity: 5 mg in 1 mL
Code: 89DS0H96TB
Classification: ACTIB
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

zinc sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70771-1849
Application NumberANDA217074
Product Classification
M
Marketing Category
C73584
G
Generic Name
zinc sulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 31, 2023
FDA Product Classification

INGREDIENTS (3)

ZINC SULFATEActive
Quantity: 3 mg in 1 mL
Code: 89DS0H96TB
Classification: ACTIB
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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zinc sulfate - FDA Drug Approval Details