Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214319
Company: SUN PHARM INDS

Products on ANDA 214319

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUGAMMADEX	SUGAMMADEX	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE;INJECTION	None (Tentative Approval)	None	No	No
SUGAMMADEX	SUGAMMADEX	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	INJECTABLE;INJECTION	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214319

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/18/2025	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.