Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 214154
Company: MAYNE PHARMA

Products on NDA 214154

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NEXTSTELLIS	DROSPIRENONE; ESTETROL	3MG;14.2MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214154

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/15/2021	ORIG-1	Approval	Type 1 - New Molecular Entity and Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214154s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214154Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214154Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214154s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214154Orig1s002ltr.pdf

Labels for NDA 214154

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214154s002lbl.pdf
04/29/2022	SUPPL-2	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214154s002lbl.pdf
04/15/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214154s000lbl.pdf