Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213978
Company: OYSTER POINT PHARMA

Products on NDA 213978

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TYRVAYA	VARENICLINE TARTRATE	EQ 0.03MG BASE/SPRAY	SPRAY;NASAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213978

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/15/2021	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213978s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213978Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/213978Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/02/2024	SUPPL-5	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213978s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213978Orig1s005ltr.pdf

Labels for NDA 213978

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/02/2024	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213978s005lbl.pdf
02/02/2024	SUPPL-5	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213978s005lbl.pdf
10/15/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213978s000lbl.pdf