Drugs@FDA: FDA Approved Drug Products

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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IC-GREEN INDOCYANINE GREEN 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None No No
IC-GREEN INDOCYANINE GREEN 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None No No
IC-GREEN INDOCYANINE GREEN 40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None No No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
02/09/1959 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/05/2015 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)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011525s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/011525s017LTR.pdf
03/02/1998 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

10/21/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/30/1995 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

03/30/1995 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

06/05/1991 SUPPL-11 Labeling

Label is not available on this site.

08/02/1989 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

IC-GREEN

INJECTABLE;INJECTION; 25MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IC-GREEN INDOCYANINE GREEN 25MG/VIAL INJECTABLE;INJECTION Prescription Yes AP 011525 AKORN
INDOCYANINE GREEN INDOCYANINE GREEN 25MG/VIAL INJECTABLE;INJECTION Prescription No AP 040811 DIAGNOSTIC GREEN

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