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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018662
Company: HOFFMANN LA ROCHE
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ACCUTANE ISOTRETINOIN 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE;ORAL Discontinued None Yes No
ACCUTANE ISOTRETINOIN 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE;ORAL Discontinued None Yes No
ACCUTANE ISOTRETINOIN 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE;ORAL Discontinued None Yes No
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
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