Pain

• FDA approval · 2024-10-31
  FDA Approved: FENTANYL SYSTEM — Supplemental Application (ALVOGEN)

  FDA approved a supplemental application for the FENTANYL SYSTEM from ALVOGEN.

• FDA approval · 2024-10-31
  FDA Approved: ACETAMINOPHEN AND CODEINE PHOSPHATE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for acetaminophen and codeine phosphate from PAI Holdings (PAI Pharma).

• FDA approval · 2024-10-31
  FDA Approved: APADAZ — Supplemental Application (Zevra Therapeutics, Inc.)

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

• FDA approval · 2024-10-31
  FDA Approved: FENTANYL TRANSDERMAL — Supplemental Application (SpecGx LLC)

  FDA approved a supplemental application for fentanyl transdermal from SpecGx LLC. The approval represents a modification to the existing pro…

• FDA approval · 2024-10-31
  FDA Approved: HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Supplemental Application (Elite Laboratories, Inc.)

  The FDA granted supplemental approval for a hydrocodone bitartrate and acetaminophen product from Elite Laboratories, Inc. under ANDA209924,…

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• FDA approval · 2024-10-31
  FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc., confirming the generic product's ap…

• FDA approval · 2024-10-31
  FDA Approved: ACETAMINOPHEN AND CODEINE PHOSPHATE — Supplemental Application (Strides Pharma Science Limited)

  The FDA approved a supplemental application for Strides Pharma Science Limited for acetaminophen and codeine phosphate tablets, a generic an…

• FDA approval · 2024-10-31
  FDA Approved: HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE — Supplemental Application (Novel Laboratories, Inc.)

  FDA approved a supplemental application for the generic Hydrocodone Bitartrate and Homatropine Methylbromide from Novel Laboratories, Inc.

• FDA approval · 2024-10-31
  FDA Approved: HYDROCODONE BITARTRATE — Supplemental Application (Alvogen Inc.)

  FDA approved a supplemental application for hydrocodone bitartrate from Alvogen Inc., under the ANDA process.

• FDA approval · 2024-10-31
  FDA Approved: OXYCODONE HYDROCHLORIDE — Supplemental Application (MAJOR PHARMACEUTICALS)

  The FDA approved a supplemental application for oxycodone hydrochloride from Major Pharmaceuticals under an ANDA.

• FDA approval · 2024-10-03
  FDA Approved: HYDROCODONE BITARTRATE AND IBUPROFEN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for Hydrocodone Bitartrate and Ibuprofen from Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2024-08-27
  FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)

  FDA approved a supplemental application for methadone hydrochloride from VistaPharm, LLC.

• FDA approval · 2024-07-26
  FDA Approved: KETOROLAC TROMETHAMINE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for a ketorolac tromethamine product by Fresenius Kabi USA, LLC under the ANDA pathway. This action …

• FDA approval · 2024-06-24
  FDA Approved: AMITRIPTYLINE HYDROCHLORIDE — Supplemental Application (Lifestar Pharma LLC)

  FDA approved a supplemental application for Amitriptyline Hydrochloride by Lifestar Pharma LLC. The submission status is AP.

• FDA approval · 2024-06-18
  FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)

  The FDA approved a supplemental application for methadone hydrochloride from VistaPharm, LLC.

• FDA approval · 2024-06-12
  FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (Hospira, Inc.)

  FDA approved Hospira's supplemental application for Buprenorphine Hydrochloride, updating the approved product's labeling and/or specificati…

• FDA approval · 2024-06-07
  FDA Approved: LEVORPHANOL TARTRATE — Supplemental Application (SpecGx LLC)

  FDA approves a supplemental application for Levorphanol tartrate submitted by SpecGx LLC. The approval pertains to changes under the supplem…

• FDA approval · 2024-05-31
  FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA)

  The FDA approved a supplemental application for methadone hydrochloride by Hikma Pharmaceuticals USA, bringing a generic version of the drug…

• FDA approval · 2024-04-08
  FDA Approved: INFANTS IBUPROFEN — Original Application (Aurohealth LLC)

  FDA approved an original ANDA for Infants Ibuprofen by Aurohealth LLC, authorizing a generic ibuprofen suspension for infants.

• FDA approval · 2024-03-20
  FDA Approved: BUPRENORPHINE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for buprenorphine from Actavis Pharma, Inc. under ANDA090819, granting regulatory clearance for this…

• FDA approval · 2024-03-20
  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 from PAI Holdings/PAI Pharma. This approval updates the product’s la…

• FDA approval · 2024-03-19
  FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Aurolife Pharma, LLC)

  FDA approved a supplemental application for Methadone Hydrochloride from Aurolife Pharma, authorizing a generic formulation of the opioid me…

• FDA approval · 2024-03-15
  FDA Approved: PROLATE — Supplemental Application (Forte Bio-Pharma LLC)

  FDA approved a supplemental application for PROLATE (oxycodone hydrochloride and acetaminophen) submitted by Forte Bio-Pharma LLC.

• FDA approval · 2024-03-15
  FDA Approved: OXYCODONE AND ACETAMINOPHEN — Supplemental Application (Lupin Pharmaceuticals,Inc.)

  FDA approved Lupin Pharmaceuticals’ supplemental ANDA for oxycodone and acetaminophen tablets, enabling the marketing of the generic product…

• FDA approval · 2024-03-12
  FDA Approved: HYDROMORPHONE HYDROCHLORIDE — Supplemental Application (Trigen Laboratories, LLC)

  The FDA approved a supplemental application for hydromorphone hydrochloride (generic) from Trigen Laboratories, LLC, authorizing a regulator…