Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206998
Company: AMNEAL PHARMS LLC

Products on ANDA 206998

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TESTOSTERONE	TESTOSTERONE	UNKNOWN	UNKNOWN	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206998

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/12/2018	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.