Ulcerative Colitis

• FDA approval · 2012-12-12
  FDA Approved: AZULFIDINE EN-TABS — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Azulfidine En-Tabs (sulfasalazine) from Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2012-11-13
  FDA Approved: BALSALAZIDE DISODIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for balsalazide disodium from Hikma Pharmaceuticals USA Inc., confirming continued approval for the …

• FDA approval · 2012-10-03
  FDA Approved: SULFASALAZINE — Supplemental Application (Sunrise Pharmaceutical, Inc.)

  The FDA approved a supplemental application for sulfasalazine from Sunrise Pharmaceutical, Inc., marking an approval action for this generic…

• FDA approval · 2012-09-28
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  The FDA approved a supplemental application for HUMIRA (adalimumab) submitted by Cordavis Limited.

• FDA approval · 2012-08-01
  FDA Approved: MERCAPTOPURINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Mercaptopurine from Hikma Pharmaceuticals USA Inc., supporting the generic product under AND…

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• FDA approval · 2012-05-24
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  FDA approved a supplemental application for HUMIRA (adalimumab) submitted by Cordavis Limited.

• FDA approval · 2012-05-02
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for ustekinumab (Stelara) from Janssen Biotech, Inc., resulting in a labeling change/addition.

• FDA approval · 2011-12-26
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  The FDA has approved a supplemental application for Humira (adalimumab) submitted by Cordavis Limited.

• FDA approval · 2011-12-13
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  FDA approved a supplemental application for HUMIRA (adalimumab) filed by Cordavis Limited.

• FDA approval · 2011-09-07
  FDA Approved: SIMPONI — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for SIMPONI (golimumab) filed by Janssen Biotech, Inc.

• FDA approval · 2011-07-14
  FDA Approved: LIALDA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for LIALDA (mesalamine) from Takeda Pharmaceuticals America, Inc.

• FDA approval · 2011-06-23
  FDA Approved: BUDESONIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for budesonide from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2011-05-27
  FDA Approved: MERCAPTOPURINE — Supplemental Application (Florida Pharmaceutical Products, LLC)

  The FDA has approved a supplemental application for mercaptopurine from Florida Pharmaceutical Products, LLC.

• FDA approval · 2011-03-23
  FDA Approved: AZATHIOPRINE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for azathioprine from Rising Pharma Holdings, Inc., under an existing ANDA. This action confirms the…

• FDA approval · 2011-02-17
  FDA Approved: INFLIXIMAB — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for infliximab from Janssen Biotech, Inc., signaling a labeling update or expansion of its appro…

• FDA approval · 2011-01-20
  FDA Approved: SULFASALAZINE — Supplemental Application (Sunrise Pharmaceutical, Inc.)

  FDA approved a supplemental application submitted by Sunrise Pharmaceutical, Inc. under ANDA040349 to market a generic form of sulfasalazine…

• FDA approval · 2010-12-28
  FDA Approved: INFLIXIMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved Janssen Biotech, Inc.'s supplemental application for infliximab. The approval updates the product's labeling and indications as…

• FDA approval · 2010-09-22
  FDA Approved: LIALDA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for LIALDA (mesalamine) from Takeda Pharmaceuticals America, Inc. The approval signals an updated la…

• FDA approval · 2010-07-29
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  The FDA has approved a supplemental application for HUMIRA (adalimumab) filed by Cordavis Limited.

• FDA approval · 2009-12-30
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for ustekinumab submitted by Janssen Biotech, Inc.

• FDA approval · 2009-10-19
  FDA Approved: AZULFIDINE EN-TABS — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Azulfidine EN-Tabs (sulfasalazine) from Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2009-08-05
  FDA Approved: DIPENTUM — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Dipentum (olsalazine sodium) submitted by Viatris Specialty LLC.

• FDA approval · 2009-04-24
  FDA Approved: SIMPONI — Original Application (Janssen Biotech, Inc.)

  FDA approved the original Biologics License Application for Simponi (golimumab) from Janssen Biotech, Inc.

• FDA approval · 2008-10-31
  FDA Approved: MESALAMINE — Original Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva Pharmaceuticals USA, Inc.'s original application for Mesalamine, a 5-aminosalicylic acid drug used in inflammatory bow…

• FDA approval · 2008-05-23
  FDA Approved: CANASA — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for CANASA (mesalamine) from Allergan, Inc., marking an additional approval for this product.