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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209088
Company: AM REGENT

Products on ANDA 209088

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CALCIUM CHLORIDE 10%	CALCIUM CHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209088

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/27/2017	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209088Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 209088

CALCIUM CHLORIDE 10%

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 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	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

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