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Last Updated: June 23, 2024

Details for New Drug Application (NDA): 216249


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NDA 216249 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 216249
Tradename:ZINC SULFATE
Applicant:Gland Pharma Ltd
Ingredient:zinc sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 216249
Physiological EffectDecreased Copper Ion Absorption
Medical Subject Heading (MeSH) Categories for 216249
Suppliers and Packaging for NDA: 216249
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZINC SULFATE zinc sulfate SOLUTION;INTRAVENOUS 216249 ANDA Piramal Critical Care Inc. 66794-239 66794-239-42 25 VIAL in 1 CARTON (66794-239-42) / 5 mL in 1 VIAL (66794-239-02)
ZINC SULFATE zinc sulfate SOLUTION;INTRAVENOUS 216249 ANDA Piramal Critical Care Inc. 66794-240 66794-240-42 25 VIAL in 1 CARTON (66794-240-42) / 10 mL in 1 VIAL (66794-240-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 25MG BASE/5ML (EQ 5MG BASE/ML)
Approval Date:May 3, 2022TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 30MG BASE/10ML (EQ 3MG BASE/ML)
Approval Date:May 3, 2022TE:APRLD:No

Profile for product number 003

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

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