Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022293
Company: AUROBINDO PHARMA

Products on NDA 022293

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ABACAVIR SULFATE	ABACAVIR SULFATE	60MG	TABLET; ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022293

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/12/2008	ORIG-1	Tentative Approval	Type 5 - New Formulation or New Manufacturer	PRIORITY	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022293s000ltr.pdf