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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208630
Company: NXDC

Products on NDA 208630

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208630

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
04/23/2024	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208630s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208630Orig1s007ltr.pdf
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-Package Insert, Labeling-Container/Carton Labels	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

Labels for NDA 208630

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/23/2024	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208630s007lbl.pdf
08/22/2018	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208630s003lbl.pdf
08/22/2018	SUPPL-3	Labeling-Container/Carton Labels	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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