Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078215
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE SODIUM FERRIC GLUCONATE COMPLEX 62.5MG/5ML INJECTABLE;INJECTION Prescription AB 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
03/31/2011 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/078215s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/28/2012 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

02/28/2012 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE

INJECTABLE;INJECTION; 62.5MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FERRLECIT SODIUM FERRIC GLUCONATE COMPLEX 62.5MG/5ML INJECTABLE;INJECTION Prescription Yes AB 020955 SANOFI AVENTIS US
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE SODIUM FERRIC GLUCONATE COMPLEX 62.5MG/5ML INJECTABLE;INJECTION Prescription No AB 078215 WEST-WARD PHARMS INT

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