Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203449
Company: INTL MEDICATION SYS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM BICARBONATE SODIUM BICARBONATE 1MEQ/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
09/19/2017 ORIG-1 Approval

Label is not available on this site.

SODIUM BICARBONATE

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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