An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021117
Company: HOSPIRA

Products on NDA 021117

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	CALCIUM CHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021117

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/28/2000	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21117ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021117_CalciumChloride.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/11/2023	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021117s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021117Orig1s025ltr.pdf
08/31/2021	SUPPL-24		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021117s024lbl.pdf
07/25/2018	SUPPL-15	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021117s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021117Orig1s015Ltr.pdf
03/18/2003	SUPPL-2	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21117scs002ltr.pdf
09/01/2000	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 021117

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/11/2023	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021117s025lbl.pdf
08/31/2021	SUPPL-24	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021117s024lbl.pdf
07/25/2018	SUPPL-15	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021117s015lbl.pdf
07/25/2018	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021117s015lbl.pdf

Therapeutic Equivalents for NDA 021117

CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 100MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CALCIUM CHLORIDE	CALCIUM CHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	217524	AMNEAL
CALCIUM CHLORIDE 10%	CALCIUM CHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	209088	AM REGENT
CALCIUM CHLORIDE 10%	CALCIUM CHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	219342	EXTROVIS
CALCIUM CHLORIDE 10%	CALCIUM CHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	203477	INTL MEDICATION SYS
CALCIUM CHLORIDE 10%	CALCIUM CHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	211553	MEDEFIL INC
CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	CALCIUM CHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	021117	HOSPIRA

Top