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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209377
Company: AM REGENT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZINC SULFATE ZINC SULFATE EQ 30MG BASE/10ML (EQ 3MG BASE/ML) SOLUTION;INTRAVENOUS Prescription AP Yes Yes
ZINC SULFATE ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION;INTRAVENOUS Prescription AP Yes Yes
ZINC SULFATE ZINC SULFATE EQ 10MG BASE/10ML (EQ 1MG BASE/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/18/2019 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209377s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209377Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209377Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/28/2020 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209377s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209377Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/28/2020 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209377s003lbl.pdf
07/18/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209377s000lbl.pdf

ZINC SULFATE

SOLUTION;INTRAVENOUS; EQ 30MG BASE/10ML (EQ 3MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ZINC SULFATE ZINC SULFATE EQ 30MG BASE/10ML (EQ 3MG BASE/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 209377 AM REGENT
ZINC SULFATE ZINC SULFATE EQ 30MG BASE/10ML (EQ 3MG BASE/ML) SOLUTION;INTRAVENOUS Prescription No AP 216249 GLAND PHARMA LTD

SOLUTION;INTRAVENOUS; EQ 25MG BASE/5ML (EQ 5MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ZINC SULFATE ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 209377 AM REGENT
ZINC SULFATE ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION;INTRAVENOUS Prescription No AP 216249 GLAND PHARMA LTD
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