Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 219990
Company: VIATRIS SPECIALTY

Products on NDA 219990

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GWYN LO		220MCG/DAY NORELGESTROMIN AND 20MCG/DAY ETHINYL ESTRADIOL	TRANSDERMAL SYSTEM	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 219990

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/28/2026	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219990Orig1s000ltr.pdf