Drugs@FDA: FDA Approved Drug Products

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

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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