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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206203
Company: EXELA PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POTASSIUM ACETATE POTASSIUM 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
12/29/2015 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/25/2017 SUPPL-2 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

POTASSIUM ACETATE

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM ACETATE POTASSIUM ACETATE 2MEQ/ML INJECTABLE;INJECTION Prescription No AP 206203 EXELA PHARMA
POTASSIUM ACETATE POTASSIUM ACETATE 2MEQ/ML INJECTABLE;INJECTION Prescription Yes AP 018896 HOSPIRA
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