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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214900
Company: GLAXOSMITHKLINE

Medication Guide

Products on NDA 214900

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BREXAFEMME	IBREXAFUNGERP CITRATE	EQ 150MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214900

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/01/2021	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214900s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214900Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214900Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/03/2025	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214900s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214900Orig1s003ltr.pdf
11/30/2022	SUPPL-2	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214900s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214900Orig1s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/214900Orig1s002.pdf
06/15/2022	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214900s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214900Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/214900Orig1s001.pdf

Labels for NDA 214900

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/03/2025	SUPPL-3	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214900s003lbl.pdf
11/03/2025	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214900s003lbl.pdf
11/30/2022	SUPPL-2	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214900s002lbl.pdf
06/15/2022	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214900s001lbl.pdf
06/01/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214900s000lbl.pdf

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