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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211965
Company: BAXTER HLTHCARE CORP

Products on ANDA 211965

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MAGNESIUM SULFATE	1GM/100ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211965

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/11/2020	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
05/10/2022	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 211965

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 1GM/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MAGNESIUM SULFATE	1GM/100ML	INJECTABLE;INJECTION	Prescription	No	AP	207966	B BRAUN MEDICAL INC
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MAGNESIUM SULFATE	1GM/100ML	INJECTABLE;INJECTION	Prescription	No	AP	211965	BAXTER HLTHCARE CORP
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MAGNESIUM SULFATE	1GM/100ML	INJECTABLE;INJECTION	Prescription	No	AP	206486	FRESENIUS KABI USA
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MAGNESIUM SULFATE	1GM/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	020488	HOSPIRA
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MAGNESIUM SULFATE	1GM/100ML	INJECTABLE;INJECTION	Prescription	No	AP	207349	HQ SPCLT PHARMA
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MAGNESIUM SULFATE	1GM/100ML	INJECTABLE;INJECTION	Prescription	No	AP	209932	MYLAN LABS LTD

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