Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077394
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM BICARBONATE SODIUM BICARBONATE 0.9MEQ/ML INJECTABLE;INJECTION Prescription AP No Yes
SODIUM BICARBONATE SODIUM BICARBONATE 1MEQ/ML INJECTABLE;INJECTION Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/09/2005 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/077394lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077394ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/09/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/077394lbl.pdf

SODIUM BICARBONATE

INJECTABLE;INJECTION; 0.9MEQ/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SODIUM BICARBONATE SODIUM BICARBONATE 0.9MEQ/ML INJECTABLE;INJECTION Prescription No AP 077394 HOSPIRA
SODIUM BICARBONATE SODIUM BICARBONATE 0.9MEQ/ML INJECTABLE;INJECTION Prescription No AP 202494 HOSPIRA INC

INJECTABLE;INJECTION; 1MEQ/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SODIUM BICARBONATE SODIUM BICARBONATE 1MEQ/ML INJECTABLE;INJECTION Prescription No AP 077394 HOSPIRA
SODIUM BICARBONATE SODIUM BICARBONATE 1MEQ/ML INJECTABLE;INJECTION Prescription No AP 202432 HOSPIRA INC
SODIUM BICARBONATE SODIUM BICARBONATE 1MEQ/ML INJECTABLE;INJECTION Prescription No AP 202494 HOSPIRA INC
SODIUM BICARBONATE SODIUM BICARBONATE 1MEQ/ML INJECTABLE;INJECTION Prescription No AP 203449 INTL MEDICATION SYS

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