Pain

• FDA approval · 2019-10-11
  FDA Approved: HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Supplemental Application (Elite Laboratories, Inc.)

  FDA approved a supplemental application for Hydrocodone Bitartrate and Acetaminophen submitted by Elite Laboratories, Inc. This action updat…

• FDA approval · 2019-10-11
  FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)

  FDA approved a supplemental application for Methadone Hydrochloride by VistaPharm, LLC.

• FDA approval · 2019-10-11
  FDA Approved: HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Supplemental Application (SpecGx LLC)

  FDA approved a supplemental application for a generic hydrocodone bitartrate and acetaminophen product from SpecGx LLC. The action concerns …

• FDA approval · 2019-10-10
  FDA Approved: PENTAZOCINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for the pentazocine hydrochloride and naloxone hydrochloride combination product, continuing its ava…

• FDA approval · 2019-10-10
  FDA Approved: HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for Hydrocodone Bitartrate and Acetaminophen from Amneal Pharmaceuticals of New York LLC under t…

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• FDA approval · 2019-10-09
  FDA Approved: BUTORPHANOL TARTRATE — Supplemental Application (Apotex Corp.)

  The FDA approved a supplemental application from Apotex Corp. for butorphanol tartrate.

• FDA approval · 2019-10-09
  FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for a generic methadone hydrochloride product from Hikma Pharmaceuticals USA Inc., granting marketin…

• FDA approval · 2019-10-09
  FDA Approved: PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals,Inc.)

  FDA approved a supplemental ANDA for pentazocine hydrochloride and naloxone hydrochloride from Lupin Pharmaceuticals, indicating regulatory …

• FDA approval · 2019-10-09
  FDA Approved: CELECOXIB — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Celecoxib submitted by Actavis Pharma, Inc.

• FDA approval · 2019-10-09
  FDA Approved: BUPRENORPHINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for buprenorphine from Sun Pharmaceutical Industries, granting approval of the generic product.

• FDA approval · 2019-10-09
  FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)

  FDA approved a supplemental application for buprenorphine hydrochloride, indicating regulatory clearance for the generic product from PAI Ho…

• FDA approval · 2019-10-09
  FDA Approved: PENTAZOCINE AND NALOXONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Pentazocine and Naloxone from Sun Pharmaceutical Industries, Inc.

• FDA approval · 2019-10-09
  FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for METHADONE HYDROCHLORIDE by Hikma Pharmaceuticals USA Inc., granting approval for a supplemental …

• FDA approval · 2019-10-07
  FDA Approved: MS CONTIN — Supplemental Application (Rhodes Pharmaceuticals L.P.)

  FDA approved a supplemental application for MS CONTIN (morphine sulfate) submitted by Rhodes Pharmaceuticals L.P.

• FDA approval · 2019-10-07
  FDA Approved: ACETAMINOPHEN AND CODEINE PHOSPHATE — Supplemental Application (SpecGx LLC)

  FDA approved a supplemental application for Acetaminophen and Codeine Phosphate from SpecGx LLC under ANDA040419. This action denotes an app…

• FDA approval · 2019-10-07
  FDA Approved: TAPENTADOL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for tapentadol hydrochloride from Hikma Pharmaceuticals USA Inc., enabling a generic version of tape…

• FDA approval · 2019-10-07
  FDA Approved: ROXICODONE — Supplemental Application (SpecGx LLC)

  FDA approved a supplemental application for ROXICODONE (oxycodone hydrochloride) submitted by SpecGx LLC.

• FDA approval · 2019-10-07
  FDA Approved: TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE — Supplemental Application (Trigen Laboratories, LLC)

  FDA approved a supplemental application for tramadol hydrochloride extended-release (Trigen Laboratories, LLC). This action confirms regulat…

• FDA approval · 2019-10-07
  FDA Approved: OXAYDO — Supplemental Application (Zyla Life Sciences US LLC)

  FDA approves a supplemental application for Oxaydo (oxycodone hydrochloride) by Zyla Life Sciences US LLC.

• FDA approval · 2019-10-07
  FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for methadone hydrochloride by Mylan Institutional LLC, resulting in updates to the product labeling…

• FDA approval · 2019-10-07
  FDA Approved: BELBUCA — Supplemental Application (BioDelivery Sciences International Inc)

  The FDA approved a supplemental application for BELBUCA (buprenorphine hydrochloride) submitted by BioDelivery Sciences International Inc.

• FDA approval · 2019-10-07
  FDA Approved: XTAMPZA ER — Supplemental Application (Collegium Pharmaceutical, Inc.)

  The FDA approved a supplemental application for XTAMPZA ER (oxycodone) by Collegium Pharmaceutical, Inc.

• FDA approval · 2019-10-07
  FDA Approved: APADAZ — Supplemental Application (Zevra Therapeutics, Inc.)

  FDA approved a supplemental application for APADAZ (benzhydrocodone and acetaminophen) from Zevra Therapeutics, Inc.

• FDA approval · 2019-10-07
  FDA Approved: BUPRENORPHINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for buprenorphine submitted by Hikma Pharmaceuticals USA Inc., authorizing changes to an approved ge…

• FDA approval · 2019-10-02
  FDA Approved: METHADONE HYDROCHLORIDE — Original Application (SpecGx LLC)

  FDA approved an original application for methadone hydrochloride from SpecGx LLC, resulting in a generic version of this opioid product.