Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208259
Company: ALCON LABS INC

Products on NDA 208259

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROCKLATAN	LATANOPROST; NETARSUDIL DIMESYLATE	0.005%;EQ 0.02% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208259

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/12/2019	ORIG-1	Approval	New Combination and New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208259s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208259Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/208259Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/01/2020	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208259s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208259Orig1s006ltr.pdf
06/01/2020	SUPPL-1			Label is not available on this site.

Labels for NDA 208259

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/01/2020	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208259s006lbl.pdf
03/12/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208259s000lbl.pdf