Irritable Bowel Syndrome with Diarrhea

• FDA approval · 2023-01-26
  FDA Approved: LOPERAMIDE HYDROCHLORIDE — Original Application (Advagen Pharma Ltd.,)

  FDA approved Advagen Pharma Ltd.'s original application for loperamide hydrochloride (a generic anti-diarrheal) to treat various forms of di…

• FDA approval · 2022-05-05
  FDA Approved: ALOSETRON HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for alosetron hydrochloride by Amneal Pharmaceuticals of New York LLC, resulting in generic approval…

• FDA approval · 2021-10-18
  FDA Approved: ALOSETRON HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for alosetron hydrochloride from Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2020-06-17
  FDA Approved: VIBERZI — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for VIBERZI (eluxadoline) submitted by Allergan, Inc. The action concerns the product and its labeli…

• FDA approval · 2019-09-16
  FDA Approved: ALOSETRON HYDROCHLORIDE — Original Application (Eywa Pharma Inc)

  FDA approved Eywa Pharma Inc's original ANDA for alosetron hydrochloride, a generic version of the IBS with diarrhea treatment.

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• FDA approval · 2019-05-28
  FDA Approved: LOPERAMIDE HYDROCHLORIDE — Supplemental Application (Aurohealth LLC)

  FDA approved a supplemental application for loperamide hydrochloride from Aurohealth LLC under ANDA206548, confirming the regulatory status …

• FDA approval · 2018-04-13
  FDA Approved: VIBERZI — Supplemental Application (Allergan, Inc.)

  FDA approves Allergan's supplemental application for VIBERZI (eluxadoline), expanding its regulatory approval.

• FDA approval · 2017-04-20
  FDA Approved: VIBERZI — Supplemental Application (Allergan, Inc.)

  FDA approved Allergan's supplemental application for VIBERZI (eluxadoline). This action approves changes requested in the supplement.

• FDA approval · 2017-02-02
  FDA Approved: VIBERZI — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for VIBERZI (eluxadoline) submitted by Allergan, Inc.

• FDA approval · 2016-12-22
  FDA Approved: ALOSETRON HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a generic version of alosetron hydrochloride (alosetron) from Amneal Pharmaceuticals of New York LLC under an original ANDA.

• FDA approval · 2015-12-15
  FDA Approved: LOPERAMIDE HYDROCHLORIDE — Original Application (Aurohealth LLC)

  FDA approved the original application for loperamide hydrochloride from Aurohealth LLC, enabling generic access to the anti-diarrheal medica…

• 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 · 2010-09-02
  FDA Approved: LOTRONEX — Supplemental Application (Legacy Pharma USA Inc.)

  FDA approved a supplemental application for Lotronex (alosetron hydrochloride) submitted by Legacy Pharma USA Inc.

• FDA approval · 2007-10-23
  FDA Approved: GOOD NEIGHBOR PHARMACY ANTI DIARRHEAL — Supplemental Application (Amerisource Bergen)

  The FDA approved a supplemental application for Good Neighbor Pharmacy Anti Diarrheal containing loperamide HCl, submitted by AmerisourceBer…