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Last Updated: June 23, 2024

Details for New Drug Application (NDA): 217074


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NDA 217074 describes ZINC SULFATE, which is a drug marketed by Abraxis Pharm, Am Regent, Fresenius Kabi Usa, Gland Pharma Ltd, and Zydus Pharms, and is included in five NDAs. It is available from six suppliers. Additional details are available on the ZINC SULFATE profile page.

The generic ingredient in ZINC SULFATE is zinc sulfate. There are thirty-eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the zinc sulfate profile page.
Summary for 217074
Tradename:ZINC SULFATE
Applicant:Zydus Pharms
Ingredient:zinc sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 217074
Physiological EffectDecreased Copper Ion Absorption
Medical Subject Heading (MeSH) Categories for 217074
Suppliers and Packaging for NDA: 217074
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZINC SULFATE zinc sulfate SOLUTION;INTRAVENOUS 217074 ANDA Zydus Pharmaceuticals USA Inc. 70710-1876 70710-1876-7 25 VIAL in 1 CARTON (70710-1876-7) / 10 mL in 1 VIAL (70710-1876-1)
ZINC SULFATE zinc sulfate SOLUTION;INTRAVENOUS 217074 ANDA Zydus Pharmaceuticals USA Inc. 70710-1877 70710-1877-7 25 VIAL in 1 CARTON (70710-1877-7) / 10 mL in 1 VIAL (70710-1877-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 10MG BASE/10ML (EQ 1MG BASE/ML)
Approval Date:Aug 22, 2023TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 25MG BASE/5ML (EQ 5MG BASE/ML)
Approval Date:Aug 22, 2023TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 30MG BASE/10ML (EQ 3MG BASE/ML)
Approval Date:Aug 22, 2023TE:APRLD:No

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