Traveler Diarrhea

• FDA approval · 2025-09-19
  FDA Approved: LOPERAMIDE HYDROCHLORIDE — Original Application (Bionpharma Inc.)

  FDA approved an oral generic version of loperamide hydrochloride from Bionpharma Inc under an Original ANDA.

• FDA approval · 2025-02-21
  FDA Approved: SULFAMETHOXAZOLE AND TRIMETHOPRIM — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application from Prasco Laboratories for sulfamethoxazole and trimethoprim, granting approval of a generic p…

• FDA approval · 2024-06-24
  FDA Approved: SULFAMETHOXAZOLE AND TRIMETHOPRIM — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for sulfamethoxazole and trimethoprim by Prasco Laboratories. This action confirms the approval of t…

• FDA approval · 2021-12-13
  FDA Approved: ANTI DIARRHEAL — Supplemental Application (H E B)

  FDA approved a supplemental application for a generic anti-diarrheal drug containing loperamide hydrochloride (LOPERAMIDE HCL).

• FDA approval · 2021-08-11
  FDA Approved: LOPERAMIDE HYDROCHLORIDE — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approved the original application for loperamide hydrochloride from Dr. Reddy's Laboratories Inc., enabling a generic product to treat d…

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• FDA approval · 2020-07-28
  FDA Approved: BACTRIM — Supplemental Application (Sun Pharmaceutical Industries, Inc)

  FDA approved a supplemental application for BACTRIM (sulfamethoxazole and trimethoprim) filed by Sun Pharmaceutical Industries, Inc. to upda…

• 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 · 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 · 2015-11-30
  FDA Approved: ANTI DIARRHEAL — Supplemental Application (H E B)

  FDA approved a supplemental application for an anti-diarrheal product containing loperamide HCl submitted by H E B, indicating regulatory ap…

• FDA approval · 2014-12-21
  FDA Approved: SULFAMETHOXAZOLE AND TRIMETHOPRIM — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for sulfamethoxazole and trimethoprim from Amneal Pharmaceuticals of New York LLC. The approval cove…

• 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 · 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…