Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204017
Company: AGILE

Products on NDA 204017

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TWIRLA	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG/24HR;0.12MG/24HR	SYSTEM;TRANSDERMAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204017

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/14/2020	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204017s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204017Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/204017Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-4	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204017s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204017Orig1s004ltr.pdf

Labels for NDA 204017

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-4	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204017s004lbl.pdf
04/29/2022	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204017s004lbl.pdf
02/14/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204017s000lbl.pdf