Diarrhea

• FDA approval · 2020-06-22
  FDA Approved: ANTI-DIARRHEAL — Supplemental Application (CHAIN DRUG MARKETING ASSOCIATION INC.)

  FDA approves a supplemental application for ANTI-DIARRHEAL containing loperamide hydrochloride. The applicant is Chain Drug Marketing Associ…

• FDA approval · 2020-06-08
  FDA Approved: GOOD NEIGHBOR PHARMACY ANTI DIARRHEAL — Supplemental Application (Amerisource Bergen)

  FDA approved a supplemental application for Good Neighbor Pharmacy Anti Diarrheal containing loperamide hydrochloride from Amerisource Berge…

• FDA approval · 2020-04-14
  FDA Approved: LOPERAMIDE HCL AND SIMETHICONE — Supplemental Application (Ohm Laboratories Inc.)

  FDA approved a supplemental application for Loperamide HCl and Simethicone from Ohm Laboratories Inc., indicating an approved modification t…

• FDA approval · 2020-02-20
  FDA Approved: DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE — Original Application (Leading Pharma, LLC)

  FDA approves a generic diphenoxylate hydrochloride and atropine sulfate product under an Original Application from Leading Pharma, LLC.

• FDA approval · 2019-12-03
  FDA Approved: ANTI DIARRHEAL ANTI GAS — Supplemental Application (Rite Aid Corporation)

  The FDA approved a supplemental application for the combination anti-diarrheal and anti-gas product ANTI DIARRHEAL ANTI GAS (loperamide hydr…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• 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 · 2019-01-31
  FDA Approved: ANTI-DIARRHEAL — Supplemental Application (CHAIN DRUG MARKETING ASSOCIATION INC.)

  The FDA approved a supplemental application for ANTI-DIARRHEAL containing loperamide hydrochloride, submitted by Chain Drug Marketing Associ…

• FDA approval · 2018-11-13
  FDA Approved: DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved an original application for a generic product of diphenoxylate hydrochloride and atropine sulfate (anti-diarrheal) by Unichem P…

• FDA approval · 2018-09-05
  FDA Approved: ANTI DIARRHEAL ANTI GAS — Original Application (Rite Aid Corporation)

  FDA approved a generic anti-diarrheal and anti-gas product containing loperamide hydrochloride and simethicone via an Original Application (…

• FDA approval · 2017-10-05
  FDA Approved: LOMOTIL — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Lomotil (diphenoxylate hydrochloride and atropine sulfate) from Pfizer Laboratories Div Pfiz…

• FDA approval · 2017-05-05
  FDA Approved: DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for the generic Diphenoxylate hydrochloride and atropine sulfate submitted by Hikma Pharmaceuticals …

• FDA approval · 2017-04-12
  FDA Approved: IMODIUM MULTI-SYMPTOM RELIEF — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for Imodium Multi-Symptom Relief, a combination of loperamide hydrochloride and dimethicone from Ken…

• FDA approval · 2017-04-12
  FDA Approved: IMODIUM A-D — Supplemental Application (Kenvue Brands LLC)

  The FDA approved a supplemental application for IMODIUM A-D (loperamide hydrochloride) from Kenvue Brands LLC, resulting in labeling changes…

• FDA approval · 2017-03-09
  FDA Approved: ANTI-DIARRHEAL — Supplemental Application (CHAIN DRUG MARKETING ASSOCIATION INC.)

  FDA approved a supplemental application for ANTI-DIARRHEAL (loperamide HCl) submitted by Chain Drug Marketing Association Inc.

• FDA approval · 2016-11-03
  FDA Approved: LOPERAMIDE HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Loperamide hydrochloride from Mylan Pharmaceuticals Inc., granting approval of a generic for…

• FDA approval · 2016-05-17
  FDA Approved: IMODIUM A-D — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for IMODIUM A-D (loperamide hydrochloride) from Kenvue Brands LLC.

• 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 · 2015-12-11
  FDA Approved: ANTI-DIARRHEAL — Supplemental Application (CHAIN DRUG MARKETING ASSOCIATION INC.)

  FDA approved a supplemental application for an anti-diarrheal product containing loperamide hydrochloride. The submission was filed by Chain…

• FDA approval · 2015-12-02
  FDA Approved: IMODIUM MULTI-SYMPTOM RELIEF — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for Imodium Multi-Symptom Relief (loperamide HCl and dimethicone) submitted by Kenvue Brands LLC.

• 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 · 2015-09-09
  FDA Approved: ANTI-DIARRHEAL — Supplemental Application (Better Living Brands, LLC)

  FDA approved a supplemental application for the anti-diarrheal product ANTI-DIARRHEAL, associated with loperamide hydrochloride (Loperamide …

• FDA approval · 2015-08-03
  FDA Approved: IMODIUM MULTI-SYMPTOM RELIEF — Supplemental Application (Kenvue Brands LLC)

  FDA approves a supplemental application for Imodium Multi-Symptom Relief, a combination of loperamide hydrochloride and dimethicone, from Ke…

• FDA approval · 2015-02-03
  FDA Approved: IMODIUM MULTI-SYMPTOM RELIEF — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for IMODIUM MULTI-SYMPTOM RELIEF (loperamide HCl and dimethicone) from Kenvue Brands LLC.

• FDA approval · 2012-12-31
  FDA Approved: MYTESI — Original Application (Napo Pharmaceuticals, Inc.)

  FDA approved the original application for MYTESI (crofelemer) by Napo Pharmaceuticals for relief of non-infectious diarrhea in adults with H…

• FDA approval · 2012-05-03
  FDA Approved: IMODIUM MULTI-SYMPTOM RELIEF — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental NDA for IMODIUM MULTI-SYMPTOM RELIEF, a combination of loperamide hydrochloride and dimethicone, from Kenvue Bra…