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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216249
Company: GLAND PHARMA LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZINC SULFATE ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION;INTRAVENOUS Prescription AP No No
ZINC SULFATE ZINC SULFATE EQ 30MG BASE/10ML (EQ 3MG BASE/ML) SOLUTION;INTRAVENOUS Prescription AP No No
ZINC SULFATE ZINC SULFATE EQ 10MG BASE/10ML (EQ 1MG BASE/ML) SOLUTION;INTRAVENOUS Prescription AP No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/03/2022 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/216249Orig1s000ltr.pdf

ZINC SULFATE

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 216145 FRESENIUS KABI USA
ZINC SULFATE ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION;INTRAVENOUS Prescription No AP 216249 GLAND PHARMA LTD
ZINC SULFATE ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION;INTRAVENOUS Prescription No AP 217074 ZYDUS PHARMS

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 216145 FRESENIUS KABI USA
ZINC SULFATE ZINC SULFATE EQ 30MG BASE/10ML (EQ 3MG BASE/ML) SOLUTION;INTRAVENOUS Prescription No AP 216249 GLAND PHARMA LTD
ZINC SULFATE ZINC SULFATE EQ 30MG BASE/10ML (EQ 3MG BASE/ML) SOLUTION;INTRAVENOUS Prescription No AP 217074 ZYDUS PHARMS

SOLUTION;INTRAVENOUS; EQ 10MG BASE/10ML (EQ 1MG 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 10MG BASE/10ML (EQ 1MG BASE/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 209377 AM REGENT
ZINC SULFATE ZINC SULFATE EQ 10MG BASE/10ML (EQ 1MG BASE/ML) SOLUTION;INTRAVENOUS Prescription No AP 216145 FRESENIUS KABI USA
ZINC SULFATE ZINC SULFATE EQ 10MG BASE/10ML (EQ 1MG BASE/ML) SOLUTION;INTRAVENOUS Prescription No AP 216249 GLAND PHARMA LTD
ZINC SULFATE ZINC SULFATE EQ 10MG BASE/10ML (EQ 1MG BASE/ML) SOLUTION;INTRAVENOUS Prescription No AP 217074 ZYDUS PHARMS
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