Postoperative Pain

• FDA approval · 2021-03-04
  FDA Approved: HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application to market a hydrocodone bitartrate and acetaminophen combination product from Amneal Pharmaceuti…

• FDA approval · 2021-03-04
  FDA Approved: OLINVYK — Supplemental Application (Trevena, Inc.)

  FDA approved a supplemental application for OLINVYK (oliceridine) from Trevena, Inc.

• FDA approval · 2020-12-03
  FDA Approved: KETOROLAC TROMETHAMINE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's ketorolac tromethamine as a generic product via an Original ANDA; ketorolac tromethamine is used for…

• FDA approval · 2020-11-04
  FDA Approved: NEVANAC — Supplemental Application (Harrow Eye, LLC)

  The FDA approved a supplemental application for NEVANAC (nepafenac) submitted by Harrow Eye, LLC.

• FDA approval · 2020-10-20
  FDA Approved: KETOROLAC TROMETHAMINE — Original Application (Eugia US LLC)

  FDA approves Eugia US LLC's original generic application for ketorolac tromethamine, authorizing its marketing as a non-steroidal anti-infla…

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• FDA approval · 2020-08-20
  FDA Approved: KETOROLAC TROMETHAMINE — Original Application (Nephron Pharmaceuticals Corporation)

  FDA approved an original ANDA for ketorolac tromethamine from Nephron Pharmaceuticals Corporation, granting generic status for this NSAID.

• FDA approval · 2020-08-07
  FDA Approved: OLINVYK — Original Application (Trevena, Inc.)

  FDA approved Trevena's OLINVYK (oliceridine) for the management of moderate-to-severe acute postoperative pain in adults.

• FDA approval · 2019-10-13
  FDA Approved: KETOROLAC TROMETHAMINE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for ketorolac tromethamine filed by Sandoz Inc under an approved ANDA.

• FDA approval · 2019-10-07
  FDA Approved: DSUVIA — Supplemental Application (AcelRx Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for DSUVIA (sufentanil) from AcelRx Pharmaceuticals, Inc.

• FDA approval · 2019-04-05
  FDA Approved: KETOROLAC TROMETHAMINE — Original Application (Micro Labs Limited)

  FDA approved the Original Application for ketorolac tromethamine from Micro Labs Limited, allowing the generic version to be marketed.

• FDA approval · 2018-11-15
  FDA Approved: KETOROLAC TROMETHAMINE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for Ketorolac tromethamine from Aurobindo Pharma Limited, granting a generic approval for short-term m…

• FDA approval · 2018-11-02
  FDA Approved: DSUVIA — Original Application (AcelRx Pharmaceuticals, Inc.)

  FDA approved DSUVIA (sufentanil) from AcelRx as an original NDA for the management of acute postoperative pain in adults.

• FDA approval · 2018-09-18
  FDA Approved: HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Hydrocodone Bitartrate and Acetaminophen from Sun Pharmaceutical Industries.

• FDA approval · 2018-08-16
  FDA Approved: KETOROLAC TROMETHAMINE — Original Application (Chartwell RX, LLC)

  FDA approved an Original Application for Ketorolac Tromethamine injectable product from Chartwell RX, LLC (ANDA210616). It represents the ap…

• FDA approval · 2018-04-06
  FDA Approved: EXPAREL — Supplemental Application (Pacira Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for EXPAREL (bupivacaine) by Pacira Pharmaceuticals, resulting in changes to the product labelin…

• FDA approval · 2018-01-16
  FDA Approved: REMIFENTANIL HYDROCHLORIDE — Original Application (Fresenius Kabi USA, LLC)

  FDA approved an original application for remifentanil hydrochloride from Fresenius Kabi USA, LLC as a generic injectable analgesic for anest…

• FDA approval · 2017-05-26
  FDA Approved: MORPHINE SULFATE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Morphine Sulfate from Actavis Pharma, Inc., permitting continued marketing of the generic produc…

• FDA approval · 2016-12-16
  FDA Approved: ACETAMINOPHEN AND CODEINE PHOSPHATE — Supplemental Application (Aurolife Pharma, LLC)

  FDA approved a supplemental application for Acetaminophen and Codeine Phosphate from Aurolife Pharma, LLC.

• FDA approval · 2016-12-16
  FDA Approved: MORPHINE SULFATE — Supplemental Application (Fresenius Kabi, USA LLC)

  FDA has approved a supplemental application for Morphine Sulfate submitted by Fresenius Kabi, USA LLC under NDA204223.

• FDA approval · 2016-11-01
  FDA Approved: KETOROLAC TROMETHAMINE — Original Application (FOSUN PHARMA USA INC)

  FDA approved the original application for a generic ketorolac tromethamine product from Fosun Pharma USA Inc, for short-term relief of moder…

• FDA approval · 2016-10-10
  FDA Approved: KETOROLAC TROMETHAMINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for ketorolac tromethamine from Sun Pharmaceutical Industries, Inc. This action confirms regulatory …

• FDA approval · 2016-06-10
  FDA Approved: SPRIX — Supplemental Application (Zyla Life Sciences US LLC)

  FDA approved a supplemental application for SPRIX (ketorolac tromethamine) submitted by Zyla Life Sciences US LLC.

• FDA approval · 2016-06-10
  FDA Approved: EXPAREL — Supplemental Application (Pacira Pharmaceuticals, Inc.)

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

• FDA approval · 2016-05-09
  FDA Approved: KETOROLAC TROMETHAMINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for ketorolac tromethamine (Sun Pharmaceutical Industries, Inc.) under an ANDA.

• FDA approval · 2016-05-09
  FDA Approved: SPRIX — Supplemental Application (Zyla Life Sciences US LLC)

  The FDA approved a supplemental application for SPRIX (ketorolac tromethamine) submitted by Zyla Life Sciences US LLC.