Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090519
Company: MATRIX LABS LTD

Products on ANDA 090519

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ABACAVIR SULFATE; LAMIVUDINE	ABACAVIR SULFATE; LAMIVUDINE	600MG; 300MG	TABLET; ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090519

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/30/2009	ORIG-1	Tentative Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090519s000ltr.pdf