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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219037
Company: MILLA PHARMS

Products on ANDA 219037

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CALCIUM GLUCONATE IN SODIUM CHLORIDE	CALCIUM GLUCONATE	1GM/50ML (20MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No
CALCIUM GLUCONATE IN SODIUM CHLORIDE	CALCIUM GLUCONATE	2GM/100ML (20MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219037

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/28/2026	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219037Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 219037

CALCIUM GLUCONATE IN SODIUM CHLORIDE

SOLUTION;INTRAVENOUS; 1GM/50ML (20MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CALCIUM GLUCONATE IN SODIUM CHLORIDE	CALCIUM GLUCONATE	1GM/50ML (20MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217174	AMNEAL
CALCIUM GLUCONATE IN SODIUM CHLORIDE	CALCIUM GLUCONATE	1GM/50ML (20MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	219037	MILLA PHARMS
CALCIUM GLUCONATE IN SODIUM CHLORIDE	CALCIUM GLUCONATE	1GM/50ML (20MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	219619	SAGENT

SOLUTION;INTRAVENOUS; 2GM/100ML (20MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CALCIUM GLUCONATE IN SODIUM CHLORIDE	CALCIUM GLUCONATE	2GM/100ML (20MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217174	AMNEAL
CALCIUM GLUCONATE IN SODIUM CHLORIDE	CALCIUM GLUCONATE	2GM/100ML (20MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	219037	MILLA PHARMS
CALCIUM GLUCONATE IN SODIUM CHLORIDE	CALCIUM GLUCONATE	2GM/100ML (20MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	219619	SAGENT

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