Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219399
Company: APOTEX CORP

Products on ANDA 219399

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RIMEGEPANT	RIMEGEPANT	75MG	TABLET, ORALLY DISINTEGRATING; ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219399

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/31/2025	ORIG-1	Tentative Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219399Orig1s000ltr.pdf