Postoperative Pain

• FDA approval · 2023-11-09
  FDA Approved: EXPAREL — Supplemental Application (Pacira Pharmaceuticals, Inc.)

  FDA approved a supplemental application for EXPAREL (bupivacaine) filed by Pacira Pharmaceuticals.

• FDA approval · 2023-09-29
  FDA Approved: OXYCODONE AND ACETAMINOPHEN — Supplemental Application (Granules Pharmaceuticals Inc.)

  FDA approved a supplemental application for Granules Pharmaceuticals Inc.'s generic oxycodone/acetaminophen product.

• FDA approval · 2023-08-10
  FDA Approved: KETOROLAC TROMETHAMINE — Supplemental Application (Nephron Pharmaceuticals Corporation)

  FDA approved a supplemental application for Ketorolac Tromethamine from Nephron Pharmaceuticals Corporation, indicating approval of an updat…

• FDA approval · 2023-08-08
  FDA Approved: KETOROLAC TROMETHAMINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Ketorolac Tromethamine from Sun Pharmaceutical Industries, confirming continued marketing of the…

• FDA approval · 2023-07-14
  FDA Approved: KETOROLAC TROMETHAMINE — Supplemental Application (Civica, Inc.)

  FDA approved a supplemental application for ketorolac tromethamine from Civica, Inc.

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• FDA approval · 2023-07-10
  FDA Approved: KETOROLAC TROMETHAMINE — Supplemental Application (Onesource Specialty Pharma Limited)

  FDA approved a supplemental application for Ketorolac tromethamine (generic) submitted by Onesource Specialty Pharma Limited under an ANDA (…

• FDA approval · 2023-06-20
  FDA Approved: KETOROLAC TROMETHAMINE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Ketorolac tromethamine as an Original Application generic for Camber Pharmaceuticals, Inc., adding a new generic entry to the m…

• FDA approval · 2023-05-10
  FDA Approved: KETOROLAC TROMETHAMINE — Original Application (Caplin Steriles Limited)

  The FDA approved the original application for a generic ketorolac tromethamine product from Caplin Steriles Limited.

• FDA approval · 2023-02-23
  FDA Approved: KETOROLAC TROMETHAMINE — Original Application (Bionpharma Inc.)

  FDA approved a generic ketorolac tromethamine product from Bionpharma Inc. (ANDA 216759) for short-term management of moderate to severe pai…

• FDA approval · 2023-02-23
  FDA Approved: KETOROLAC TROMETHAMINE — Original Application (Leading Pharma, LLC)

  FDA approves Ketorolac tromethamine from Leading Pharma, LLC under an Original Application for a generic formulation.

• FDA approval · 2022-12-13
  FDA Approved: ZYNRELEF — Supplemental Application (Heron Therapeutics, Inc.)

  FDA approved a supplemental application for ZYNRELEF (bupivacaine and meloxicam) from Heron Therapeutics, expanding its label/indication for…

• FDA approval · 2022-11-02
  FDA Approved: KETOROLAC TROMETHAMINE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals Inc.'s original application for ketorolac tromethamine, enabling a generic version of this NSAID analge…

• FDA approval · 2022-10-21
  FDA Approved: KETOROLAC TROMETHAMINE — Original Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approved the original application for a generic ketorolac tromethamine product (Toradol) manufactured by Zydus Pharmaceuticals (USA) Inc…

• FDA approval · 2022-10-21
  FDA Approved: KETOROLAC TROMETHAMINE — Original Application (ATNAHS PHARMA US LIMITED)

  FDA approved a generic ketorolac tromethamine product from ATNAHS PHARMA US LIMITED under Original Application ANDA216407.

• FDA approval · 2022-08-25
  FDA Approved: KETOROLAC TROMETHAMINE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' original application for ketorolac tromethamine (an NSAID) for short-term management of acute pain, inc…

• FDA approval · 2022-03-09
  FDA Approved: CELECOXIB — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for Celecoxib from Micro Labs Limited under an ANDA.

• FDA approval · 2022-01-11
  FDA Approved: CELECOXIB — Supplemental Application (NIVAGEN PHARMACEUTICALS, INC.)

  The FDA approved a supplemental application for Celecoxib submitted by NIVAGEN Pharmaceuticals, Inc., for a generic Celecoxib product.

• FDA approval · 2021-12-08
  FDA Approved: ZYNRELEF — Supplemental Application (Heron Therapeutics, Inc.)

  FDA approved a supplemental application for ZYNRELEF (bupivacaine and meloxicam) from Heron Therapeutics, Inc. This action updates the produ…

• FDA approval · 2021-06-25
  FDA Approved: SUFENTANIL CITRATE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for sufentanil citrate from Hospira, Inc., under ANDA074534.

• FDA approval · 2021-05-12
  FDA Approved: ZYNRELEF — Original Application (Heron Therapeutics, Inc.)

  FDA approved ZYNRELEF, a fixed-dose combination of bupivacaine and meloxicam, for postoperative analgesia. The product combines a local anes…

• FDA approval · 2021-05-06
  FDA Approved: MITIGO — Supplemental Application (Piramal Critical Care, Inc.)

  FDA approved a supplemental submission for MITIGO (morphine sulfate) by Piramal Critical Care, Inc., approving changes to an existing morphi…

• FDA approval · 2021-04-28
  FDA Approved: KETOROLAC TROMETHAMINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' supplemental application for ketorolac tromethamine.

• FDA approval · 2021-04-28
  FDA Approved: KETOROLAC TROMETHAMINE — Supplemental Application (FOSUN PHARMA USA INC)

  FDA approved a supplemental application for ketorolac tromethamine from Fosun Pharma USA Inc, under the ANDA pathway.

• FDA approval · 2021-04-02
  FDA Approved: EXPAREL — Supplemental Application (Pacira Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for EXPAREL (bupivacaine) filed by Pacira Pharmaceuticals.

• FDA approval · 2021-03-22
  FDA Approved: EXPAREL — Supplemental Application (Pacira Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for EXPAREL (liposomal bupivacaine) from Pacira Pharmaceuticals, Inc.