Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210906
Company: HQ SPCLT PHARMA

Products on NDA 210906

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	None	Yes	Yes
CALCIUM GLUCONATE IN SODIUM CHLORIDE	CALCIUM GLUCONATE	2GM/100ML (20MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
CALCIUM GLUCONATE IN SODIUM CHLORIDE	CALCIUM GLUCONATE	1GM/100ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210906

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/29/2018	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210906s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210906Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210906Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/28/2020	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210906s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210906Orig1s004ltr.pdf

Labels for NDA 210906

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/28/2020	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210906s004lbl.pdf
10/29/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210906s000lbl.pdf