You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: June 23, 2024

Details for New Drug Application (NDA): 216249

✉ Email this page to a colleague

« Back to Dashboard

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
Applicant:Gland Pharma Ltd
Ingredient:zinc sulfate
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

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.