Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021961
Company: SYNTHON PHARMS

• Other Important Information from FDA

Products on NDA 21961

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SIMVASTATIN	SIMVASTATIN	10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No
SIMVASTATIN	SIMVASTATIN	20MG	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No
SIMVASTATIN	SIMVASTATIN	40MG	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No
SIMVASTATIN	SIMVASTATIN	80MG	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No

Labels for NDA 021961

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/09/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021961lbl.pdf