Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219386
Company: HETERO LABS LTD UNIT III

Products on ANDA 219386

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUVOREXANT	SUVOREXANT	10MG	TABLET	None (Tentative Approval)	None	No	No
SUVOREXANT	SUVOREXANT	5MG	TABLET	None (Tentative Approval)	None	No	No
SUVOREXANT	SUVOREXANT	40MG	TABLET	None (Tentative Approval)	None	No	No
SUVOREXANT	SUVOREXANT	30MG	TABLET	None (Tentative Approval)	None	No	No
SUVOREXANT	SUVOREXANT	20MG	TABLET	None (Tentative Approval)	None	No	No
SUVOREXANT	SUVOREXANT	15MG	TABLET	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219386

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/2025	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.