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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214805
Company: MILLA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM ACETATE SODIUM ACETATE 2MEQ/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
05/04/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214805Orig1s000ltr.pdf

SODIUM ACETATE

INJECTABLE;INJECTION; 2MEQ/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SODIUM ACETATE SODIUM ACETATE 2MEQ/ML INJECTABLE;INJECTION Prescription Yes AP 018893 HOSPIRA
SODIUM ACETATE SODIUM ACETATE 2MEQ/ML INJECTABLE;INJECTION Prescription No AP 214805 MILLA PHARMS
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