Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021164
Company: FABRE KRAMER

Products on NDA 021164

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EXXUA	GEPIRONE HYDROCHLORIDE	EQ 18.2MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes
EXXUA	GEPIRONE HYDROCHLORIDE	EQ 36.3MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
EXXUA	GEPIRONE HYDROCHLORIDE	EQ 54.5MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
EXXUA	GEPIRONE HYDROCHLORIDE	EQ 72.6MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021164

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/22/2023	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021164s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021164Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/021164Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/07/2025	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021164Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021164Orig1s001ltr.pdf

Labels for NDA 021164

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/07/2025	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021164Orig1s001lbl.pdf
09/22/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021164s000lbl.pdf