Dyspepsia

• FDA approval · 2026-02-12
  FDA Approved: PEPCID AC MAXIMUM STRENGTH — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for Pepcid AC Maximum Strength, a famotidine-containing product from Kenvue Brands LLC.

• FDA approval · 2025-12-10
  FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approved ANI Pharmaceuticals' original application for a generic omeprazole and sodium bicarbonate combination product.

• FDA approval · 2025-09-30
  FDA Approved: PEPCID COMPLETE — Supplemental Application (Lil' Drug Store Products, Inc.)

  FDA approved a supplemental application for Pepcid Complete (famotidine with calcium carbonate and magnesium hydroxide) chewable tablets to …

• FDA approval · 2025-07-16
  FDA Approved: FAMOTIDINE — Original Application (Sagent Pharmaceuticals)

  FDA approved the original application for famotidine from Sagent Pharmaceuticals, marking the approval of a generic product.

• FDA approval · 2025-07-09
  FDA Approved: FAMOTIDINE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original abbreviated new drug application (ANDA) for famotidine from Aurobindo Pharma Limited, a generic version of famotid…

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• FDA approval · 2025-01-17
  FDA Approved: PEPCID COMPLETE — Supplemental Application (Lil' Drug Store Products, Inc.)

  The FDA approved a supplemental application to authorize Pepcid Complete chewable tablets (famotidine with calcium carbonate and magnesium h…

• FDA approval · 2024-11-22
  FDA Approved: NAPROXEN AND ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s supplemental application for Naproxen and Esomeprazole Magnesium (ANDA 213699), establishing a generic…

• FDA approval · 2023-09-14
  FDA Approved: FAMOTIDINE — Original Application (Micro Labs Limited)

  FDA approved Micro Labs Limited's original ANDA for famotidine. This approval allows the marketing of a generic famotidine product.

• FDA approval · 2023-08-17
  FDA Approved: FAMOTIDINE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' original application for famotidine, a generic H2 blocker used to treat ulcers and gastroesophageal ref…

• FDA approval · 2022-12-23
  FDA Approved: CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for the combination drug chlordiazepoxide hydrochloride and clidinium bromide (brand name Librax) ma…

• FDA approval · 2022-09-30
  FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)

  FDA granted a supplemental approval for Good Neighbor Pharmacy Omeprazole (omeprazole) from AmerisourceBergen.

• FDA approval · 2019-01-31
  FDA Approved: RANITIDINE — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved an original ANDA for ranitidine from Rising Pharma Holdings, Inc., enabling the marketing of a generic ranitidine product.

• FDA approval · 2018-08-20
  FDA Approved: RANITIDINE — Original Application (Granules India Ltd)

  FDA approved Granules India Ltd's original application for ranitidine (generic). The product is intended for conditions such as duodenal and…

• FDA approval · 2015-05-06
  FDA Approved: PEPCID AC MAXIMUM STRENGTH — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for Pepcid AC Maximum Strength (famotidine) submitted by Kenvue Brands LLC. This action expands the …

• FDA approval · 2015-04-20
  FDA Approved: PEPCID AC MAXIMUM STRENGTH — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for Pepcid AC Maximum Strength (famotidine) filed by Kenvue Brands LLC to update the OTC product lab…

• FDA approval · 2014-12-19
  FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved a supplemental application for omeprazole and sodium bicarbonate from Oceanside Pharmaceuticals, indicating an approved change …

• FDA approval · 2014-05-30
  FDA Approved: FAMOTIDINE — Original Application (Akorn)

  The FDA approved Akorn's original application for a generic famotidine product, enabling market entry of a competitor to the brand-name drug…

• FDA approval · 2013-12-07
  FDA Approved: PEPCID COMPLETE — Supplemental Application (Lil' Drug Store Products, Inc.)

  FDA approved a supplemental application for Pepcid Complete, a chewable tablet that combines famotidine with calcium carbonate and magnesium…

• FDA approval · 2012-12-19
  FDA Approved: FAMOTIDINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for famotidine from Teva Pharmaceuticals USA, Inc., signaling an approved modification to the produc…

• FDA approval · 2012-12-17
  FDA Approved: FAMOTIDINE — Original Application (Lupin Pharmaceuticals,Inc.)

  FDA approves Lupin Pharmaceuticals' famotidine as a generic product under an original ANDA, authorizing its marketing for approved indicatio…

• FDA approval · 2012-02-29
  FDA Approved: ACID REDUCER — Original Application (WinCo Foods, LLC)

  FDA approved an original application for a generic ranitidine hydrochloride product called ACID REDUCER by WinCo Foods, LLC.

• FDA approval · 2010-10-29
  FDA Approved: FAMOTIDINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  The FDA approved a supplemental application for famotidine from Dr. Reddy's Laboratories Limited, authorizing a modification to an existing …

• FDA approval · 2010-10-27
  FDA Approved: RANITIDINE — Supplemental Application (Pharmaceutical Associates, Inc.)

  The FDA approved a supplemental application for ranitidine submitted by Pharmaceutical Associates, Inc. The approval updates the product's e…

• FDA approval · 2010-07-15
  FDA Approved: FAMOTIDINE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved a supplemental application for famotidine from Alembic Pharmaceuticals Inc., adding approved changes to the product under the A…

• FDA approval · 2010-05-27
  FDA Approved: FAMOTIDINE — Original Application (Navinta LLC)

  FDA approves Navinta LLC's original application for famotidine. This approval permits a generic version of famotidine to enter the market.