Hepatic Encephalopathy

• FDA approval · 2026-04-14
  FDA Approved: KRISTALOSE — Supplemental Application (Cumberland Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Kristalose (lactulose) from Cumberland Pharmaceuticals Inc.

• FDA approval · 2025-03-14
  FDA Approved: LACTULOSE — Original Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved an original application for lactulose as a generic drug, manufactured by PAI Holdings (dba PAI Pharma).

• FDA approval · 2024-12-13
  FDA Approved: LACTULOSE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a generic lactulose product from Sun Pharmaceutical Industries as an Original Application (ANDA 218858).

• FDA approval · 2024-09-17
  FDA Approved: LACTULOSE — Supplemental Application (Xttrium Laboratories, Inc.)

  FDA approved a supplemental application for lactulose submitted by Xttrium Laboratories, Inc., authorizing a new generic lactulose product.

• FDA approval · 2024-02-20
  FDA Approved: LACTULOSE SOLUTION — Supplemental Application (Bajaj Medical, LLC)

  FDA approved Bajaj Medical, LLC's supplemental application for Lactulose Solution USP (10 g/15 mL), confirming continued availability of the…

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• FDA approval · 2021-09-08
  FDA Approved: LACTULOSE — Supplemental Application (APOZEAL PHARMACEUTICALS INC)

  FDA approved a supplemental application for Lactulose submitted by APOZEAL PHARMACEUTICALS INC, indicating an update to labeling and/or indi…

• FDA approval · 2021-08-16
  FDA Approved: LACTULOSE — Supplemental Application (APOZEAL PHARMACEUTICALS INC)

  FDA approved a supplemental application for Lactulose submitted by APOZEAL PHARMACEUTICALS INC, resulting in an approved labeling/indication…

• FDA approval · 2020-03-24
  FDA Approved: LACTULOSE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  The FDA approved a supplemental application for lactulose from PAI Holdings (PAI Pharma), updating its labeling and potentially expanding th…

• FDA approval · 2018-11-23
  FDA Approved: LACTULOSE — Original Application (Chartwell RX, LLC)

  FDA approves Lactulose from Chartwell RX, LLC under ANDA209517; a generic formulation indicated for constipation and hepatic encephalopathy.

• FDA approval · 2018-06-11
  FDA Approved: LACTULOSE — Original Application (APOZEAL PHARMACEUTICALS INC)

  FDA approved Lactulose under an original application from Apozeal Pharmaceuticals Inc.

• FDA approval · 2015-03-27
  FDA Approved: LACTULOSE — Original Application (APOZEAL PHARMACEUTICALS INC)

  FDA approved the original application for lactulose from ApoZeal Pharmaceuticals Inc, enabling generic lactulose products for constipation a…

• FDA approval · 2014-03-12
  FDA Approved: XIFAXAN — Supplemental Application (Salix Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for XIFAXAN (rifaximin) filed by Salix Pharmaceuticals, Inc., resulting in an update to the prod…

• FDA approval · 2012-01-25
  FDA Approved: ENULOSE — Original Application (Actavis Pharma, Inc.)

  FDA approved the original ANDA for Enulose (lactulose) by Actavis Pharma, establishing a generic lactulose product.

• FDA approval · 2012-01-25
  FDA Approved: CONSTULOSE — Original Application (Actavis Pharma, Inc.)

  FDA approved Actavis Pharma, Inc.'s CONSTULOSE as an original generic application for lactulose. Lactulose is used as a laxative for constip…