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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213071
Company: NIVAGEN PHARMS INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CALCIUM GLUCONATE CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION;INTRAVENOUS Prescription AP No No
CALCIUM GLUCONATE CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION;INTRAVENOUS Prescription AP No No
CALCIUM GLUCONATE CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION;INTRAVENOUS 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
10/14/2022 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213071Orig1s000ltr.pdf

CALCIUM GLUCONATE

SOLUTION;INTRAVENOUS; 1GM/10ML (100MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CALCIUM GLUCONATE CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 208418 FRESENIUS KABI USA
CALCIUM GLUCONATE CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 213071 NIVAGEN PHARMS INC

SOLUTION;INTRAVENOUS; 5GM/50ML (100MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CALCIUM GLUCONATE CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 208418 FRESENIUS KABI USA
CALCIUM GLUCONATE CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 213071 NIVAGEN PHARMS INC
CALCIUM GLUCONATE CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 217689 SOMERSET

SOLUTION;INTRAVENOUS; 10GM/100ML (100MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CALCIUM GLUCONATE CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 216541 B BRAUN MEDICAL INC
CALCIUM GLUCONATE CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 208418 FRESENIUS KABI USA
CALCIUM GLUCONATE CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 213071 NIVAGEN PHARMS INC
CALCIUM GLUCONATE CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 217689 SOMERSET
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