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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218312
Company: BRIGHTGENE

Products on ANDA 218312

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION;SUBCUTANEOUS	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218312

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/18/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

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