Pain

• FDA approval · 2024-10-31
  FDA Approved: BUTRANS — Supplemental Application (Purdue Pharma LP)

  FDA approved a supplemental application for BUTRANS (buprenorphine) submitted by Purdue Pharma LP.

• FDA approval · 2024-10-31
  FDA Approved: MORPHINE SULFATE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Actavis Pharma's morphine sulfate to market a generic morphine sulfate product. This action auth…

• FDA approval · 2024-10-31
  FDA Approved: HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Supplemental Application (Eywa Pharma Inc)

  FDA approved Eywa Pharma Inc's supplemental application for hydrocodone bitartrate and acetaminophen (hydrocodone/acetaminophen) under ANDA …

• 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., authorizing changes under the appro…

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

  FDA approved Lupin Pharmaceuticals' supplemental application for hydrocodone bitartrate and acetaminophen.

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• FDA approval · 2024-10-31
  FDA Approved: HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Supplemental Application (Cranbury Pharmaceuticals, LLC)

  FDA approved a supplemental application for a generic Hydrocodone Bitartrate and Acetaminophen product from Cranbury Pharmaceuticals, LLC.

• FDA approval · 2024-10-31
  FDA Approved: PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals,Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for pentazocine hydrochloride and naloxone hydrochloride. The approval updates …

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

  FDA approves a supplemental application for Roxicodone (oxycodone hydrochloride) submitted by SpecGx LLC, indicating changes to the product …

• FDA approval · 2024-10-31
  FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)

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

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

  FDA approved a supplemental application for methadone hydrochloride (generic), enabling continued marketing of the product.

• FDA approval · 2024-10-31
  FDA Approved: MORPHINE SULFATE — Supplemental Application (Cranbury Pharmaceuticals, LLC)

  The FDA approved a supplemental application for morphine sulfate, submitted by Cranbury Pharmaceuticals, LLC.

• FDA approval · 2024-10-31
  FDA Approved: BUPRENORPHINE — Supplemental Application (INGENUS PHARMACEUTICALS, LLC)

  The FDA approved a supplemental application for buprenorphine from Ingenus Pharmaceuticals, granting approval of a generic buprenorphine pro…

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

  FDA approved Lupin Pharmaceuticals' supplemental application for a generic hydrocodone bitartrate and acetaminophen product. The approval ad…

• FDA approval · 2024-10-31
  FDA Approved: HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Hydrocodone Bitartrate and Acetaminophen manufactured by Hikma Pharmaceuticals USA Inc., indicat…

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

  The FDA approved a supplemental application for oxycodone hydrochloride from SpecGx LLC, a generic opioid analgesic. The approval clears the…

• FDA approval · 2024-10-31
  FDA Approved: PENTAZOCINE AND NALOXONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Pentazocine and Naloxone from Sun Pharmaceutical Industries, Inc., authorizing changes reque…

• FDA approval · 2024-10-31
  FDA Approved: PROLATE — Supplemental Application (Forte Bio-Pharma LLC)

  FDA approves a supplemental application for PROLATE (oxycodone hydrochloride and acetaminophen) from Forte Bio-Pharma LLC. The action pertai…

• FDA approval · 2024-10-31
  FDA Approved: BUPRENORPHINE TRANSDERMAL SYSTEM — Supplemental Application (Alvogen Inc.)

  FDA approved a supplemental application for the buprenorphine transdermal system from Alvogen Inc., under the ANDA program. This action typi…

• FDA approval · 2024-10-31
  FDA Approved: OXYCODONE HYDROCHLORIDE — Supplemental Application (Aurolife Pharma, LLC)

  FDA approves a supplemental application for oxycodone hydrochloride from Aurolife Pharma, LLC, enabling a generic oxycodone hydrochloride pr…

• FDA approval · 2024-10-31
  FDA Approved: MEPERIDINE HYDROCHLORIDE — Supplemental Application (EPIC PHARMA, LLC)

  The FDA approved a supplemental application for meperidine hydrochloride from Epic Pharma, LLC.

• FDA approval · 2024-10-31
  FDA Approved: TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for a generic tramadol hydrochloride and acetaminophen tablet from Aurobindo Pharma Limited, aut…

• FDA approval · 2024-10-31
  FDA Approved: HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Supplemental Application (Cranbury Pharmaceuticals, LLC)

  FDA approved a supplemental application for Hydrocodone Bitartrate and Acetaminophen from Cranbury Pharmaceuticals, LLC. This approval permi…

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

  FDA approves SpecGx LLC's supplemental application for methadone hydrochloride.

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

  FDA approved a supplemental application for hydrocodone bitartrate and acetaminophen by KVK-Tech, Inc., validating regulatory approval for t…

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

  The FDA approved a supplemental application for Oxycodone Hydrochloride (SpecGx LLC) under ANDA210758.