Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018662
Company: HOFFMANN LA ROCHE

• Medication Guide

• Other Important Information from FDA

• REMS

Products on NDA 18662

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACCUTANE	ISOTRETINOIN	10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	Yes	No
ACCUTANE	ISOTRETINOIN	40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	Yes	No
ACCUTANE	ISOTRETINOIN	20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	Yes	No

Labels for NDA 018662

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/01/2010	SUPPL-60	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018662s060lbl.pdf
11/19/2008	SUPPL-59	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018662s059lbl.pdf
10/03/2007	SUPPL-58	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018662s058lbl.pdf
08/12/2005	SUPPL-56	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018662s056lbl.pdf
08/24/2004	SUPPL-54	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18662s054lbl.pdf
08/27/2003	SUPPL-52	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18662slr048,052_accutane_lbl.pdf
08/27/2003	SUPPL-48	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18662slr048,052_accutane_lbl.pdf
06/20/2002	SUPPL-51	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18662s051lbl.pdf
05/02/2002	SUPPL-43	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18662s043lbl.pdf
02/15/2002	SUPPL-46	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18662s046lbl.pdf
12/31/2001	SUPPL-45	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18662s41s45lbl.pdf
12/31/2001	SUPPL-41	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18662s41s45lbl.pdf
10/30/2001	SUPPL-44	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18662s44lbl.pdf