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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011525
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IC-GREEN INDOCYANINE GREEN 25MG/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
IC-GREEN INDOCYANINE GREEN 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None No No
IC-GREEN INDOCYANINE GREEN 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None No No
IC-GREEN INDOCYANINE GREEN 40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None No No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/17/2022 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011525Orig1s036lbl.pdf
03/17/2022 SUPPL-36 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011525Orig1s036lbl.pdf
10/05/2015 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011525s027lbl.pdf
09/22/2006 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011525s017lbl.pdf
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