Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208630
Company: NXDC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLEOLAN AMINOLEVULINIC ACID HYDROCHLORIDE 1.5GM/VIAL FOR SOLUTION;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/06/2017 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208630s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208630Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208630Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/19/2019 SUPPL-4 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208630Orig1s004ltr.pdf
08/22/2018 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208630s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208630Orig1s003Ltr.pdf
06/12/2018 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208630s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208630Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/22/2018 SUPPL-3 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208630s003lbl.pdf
08/22/2018 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208630s003lbl.pdf
06/12/2018 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208630s002lbl.pdf
06/06/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208630s000lbl.pdf

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