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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204396
Company: MICRO LABS

Products on ANDA 204396

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EMTRICITABINE	EMTRICITABINE	200MG	CAPSULE;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204396

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/04/2018	ORIG-1	Tentative Approval				Label is not available on this site.

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