Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209377
Company: AM REGENT

Products on NDA 209377

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	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209377

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

Labels for NDA 209377

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

Therapeutic Equivalents for NDA 209377

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	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 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 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