Constipation

• FDA approval · 2021-11-30
  FDA Approved: POLYETHYLENE GLYCOL 3350 — Supplemental Application (SKY Packaging)

  FDA approved a supplemental application for polyethylene glycol 3350 submitted by SKY Packaging.

• FDA approval · 2021-10-13
  FDA Approved: PURELAX — Supplemental Application (CVS Pharmacy)

  FDA approved a supplemental application for PureLax (polyethylene glycol 3350) submitted by CVS Pharmacy.

• 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 · 2021-05-14
  FDA Approved: GAVILYTE-H AND BISACODYL — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Gavilyte-H and Bisacodyl, a combination laxative tablet containing polyethylene glycol 3350 …

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• FDA approval · 2021-04-27
  FDA Approved: MIRALAX — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for Miralax (polyethylene glycol 3350) from Bayer HealthCare LLC.

• FDA approval · 2021-04-14
  FDA Approved: POLYETHYLENE GLYCOL 3350 — Original Application (BluePoint Laboratories)

  FDA approved BluePoint Laboratories' polyethylene glycol 3350 as an original application (ANDA 214990) for use as a laxative. This confirms …

• FDA approval · 2020-12-21
  FDA Approved: GAVILYTE-N — Supplemental Application (Lupin Pharmaceuticals,Inc.)

  FDA approved the supplemental application for GAVILYTE-N, a polyethylene glycol-3350 with electrolytes laxative, manufactured by Lupin Pharm…

• FDA approval · 2020-04-03
  FDA Approved: POLYETHYLENE GLYCOL — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for polyethylene glycol 3350 by BluePoint Laboratories.

• 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 · 2018-12-21
  FDA Approved: POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES - UNFLAVORED — Original Application (Strides Pharma Science Limited)

  FDA approves Strides Pharma Science Limited's polyethylene glycol 3350 with electrolytes - unflavored as an original generic application.

• 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 · 2018-10-12
  FDA Approved: MIRALAX — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for MiraLAX (polyethylene glycol 3350) submitted by Bayer HealthCare LLC.

• 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 · 2018-05-04
  FDA Approved: MIRALAX — Supplemental Application (Bayer HealthCare LLC.)

  The FDA approved a supplemental application for MIRALAX (polyethylene glycol 3350) from Bayer HealthCare LLC, updating its labeling.

• FDA approval · 2018-04-24
  FDA Approved: MIRALAX — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for MIRALAX (polyethylene glycol 3350) from Bayer HealthCare LLC.

• FDA approval · 2018-04-09
  FDA Approved: POLYETHYLENE GLYCOL 3350 — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's polyethylene glycol 3350 as an original generic application (ANDA 209017), expanding access to a lax…

• FDA approval · 2017-10-04
  FDA Approved: MIRALAX — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for Miralax (polyethylene glycol 3350) from Bayer HealthCare LLC.

• FDA approval · 2016-10-28
  FDA Approved: POLYETHYLENE GLYCOL 3350 NF — Original Application (SUNRISE PHARMACEUTICAL, INC)

  FDA approved Sunrise Pharmaceutical's original ANDA for polyethylene glycol 3350 NF, establishing a generic version of the widely used laxat…

• FDA approval · 2016-10-21
  FDA Approved: MIRALAX — Supplemental Application (Bayer HealthCare LLC.)

  The FDA approved a supplemental application for Miralax (polyethylene glycol 3350) submitted by Bayer HealthCare LLC.

• FDA approval · 2016-09-30
  FDA Approved: MIRALAX — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for Miralax (polyethylene glycol 3350) submitted by Bayer HealthCare LLC., resulting in an update to…

• FDA approval · 2016-08-24
  FDA Approved: POLYETHYLENE GLYCOL 3350 — Original Application (Major Pharmaceuticals)

  FDA approved the original ANDA for polyethylene glycol 3350 (INSTALAX) by Major Pharmaceuticals, a laxative used to treat constipation.

• FDA approval · 2016-01-12
  FDA Approved: PURELAX — Supplemental Application (CVS Pharmacy)

  FDA approved a supplemental application for PureLax (polyethylene glycol 3350) submitted by CVS Pharmacy. It is a laxative approved for the …

• FDA approval · 2015-12-15
  FDA Approved: POLYETHYLENE GLYCOL 3350 — Original Application (SKY Packaging)

  FDA approved an Original Application for polyethylene glycol 3350 from SKY Packaging, making it an approved generic laxative. The product is…

• FDA approval · 2015-10-29
  FDA Approved: MIRALAX — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for MIRALAX (polyethylene glycol 3350) submitted by Bayer HealthCare LLC.