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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206185
Company: SUN PHARM

Products on NDA 206185

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XELPROS	LATANOPROST	0.005%	EMULSION;OPHTHALMIC	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206185

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/12/2018	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206185s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206185Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/206185Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/09/2024	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206185s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/206185Orig1s019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/206185Orig1s019ltr.pdf
12/21/2020	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/2016185s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206185Orig1s009ltr.pdf

Labels for NDA 206185

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/09/2024	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206185s019lbl.pdf
12/21/2020	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/2016185s009lbl.pdf
09/12/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206185s000lbl.pdf

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