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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218059
Company: APOTEX

Products on ANDA 218059

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 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218059

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/10/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/28/2024	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 218059

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	218059	APOTEX
ZINC SULFATE	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	219585	ASPIRO
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
ZINC SULFATE	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214597	NIVAGEN PHARMS INC
ZINC SULFATE	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217624	RK PHARMA
ZINC SULFATE	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216135	SOMERSET THERAPS LLC
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	218059	APOTEX
ZINC SULFATE	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	219585	ASPIRO
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
ZINC SULFATE	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214597	NIVAGEN PHARMS INC
ZINC SULFATE	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217624	RK PHARMA
ZINC SULFATE	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217074	ZYDUS PHARMS

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