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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217689
Company: SOMERSET

Products on ANDA 217689

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CALCIUM GLUCONATE	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No
CALCIUM GLUCONATE	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217689

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/19/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217689

CALCIUM GLUCONATE

SOLUTION;INTRAVENOUS; 5GM/50ML (100MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CALCIUM GLUCONATE	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216611	AMNEAL
CALCIUM GLUCONATE	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	208418	FRESENIUS KABI USA
CALCIUM GLUCONATE	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	213071	NIVAGEN PHARMS INC
CALCIUM GLUCONATE	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217689	SOMERSET

SOLUTION;INTRAVENOUS; 10GM/100ML (100MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CALCIUM GLUCONATE	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216611	AMNEAL
CALCIUM GLUCONATE	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216541	B BRAUN MEDICAL INC
CALCIUM GLUCONATE	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	208418	FRESENIUS KABI USA
CALCIUM GLUCONATE	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	213071	NIVAGEN PHARMS INC
CALCIUM GLUCONATE	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217689	SOMERSET

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